Health News

Sarepta shares plunge 60 percent after FDA questions drug trial

A view shows the U.S. Food and Drug Administration (FDA) logo at its headquarters in Silver SpringSarepta Therapeutics Inc lost more than 60 percent of its market value after it was advised by the U.S. health regulator to find new ways to test its flagship treatment for a rare muscle disorder.

The U.S. Food and Drug Administration (FDA), citing new data and the failed trial of a competing drug, said the design and goals of Sarepta’s current trial might not be sufficient to win marketing approval for its drug.

Sarepta’s shares fell 62 percent, wiping more than $750 million off the company’s market value and making the stock the biggest percentage loser on the Nasdaq on Tuesday afternoon. At least three brokerages downgraded the stock.

“Everything I thought could have gone wrong has gone wrong – and then more stuff has gone wrong,” said Chad Messer, an analyst at investment banking and asset management firm Needham & Co, who downgraded Sarepta’s stock to “hold” from “buy”.

Sarepta is developing the drug, eteplirsen, as a treatment for Duchenne muscular dystrophy (DMD), a degenerative disorder that hampers muscle movement and affects one in 3,600 newborn boys.

Investors had been betting on a breakthrough.

Before Tuesday’s fall, Sarepta’s stock had more than doubled since October 2012, when data from a mid-stage trial showed that eteplirsen significantly improved walking ability in DMD patients.

But the FDA has now suggested that eteplirsen be tested against a placebo in a new, and potentially larger, trial, Sarepta said on Tuesday.

A placebo-controlled trial, it said, would be better than current trials in removing bias in walking ability that might be susceptible to individual effort or patient care.

“…It seems worthwhile to consider selection of other endpoints and/or populations for the next trial of eteplirsen,” Sarepta said it was told by the FDA in a meeting last week.

In its remarks, the FDA cited the recent failure of the trial of a rival drug, drisapersen, being developed by GlaxoSmithKline and Prosensa Holding NV.

That drug, like eteplirsen, works by increasing the production of a protein called dystrophin, the lack of which is the chief cause of DMD.

It failed to show a statistically significant improvement in the distance that DMD patients could walk in six minutes compared with placebo in a late-stage trial in September.

Prosensa’s shares, which had lost about 85 percent of their value since the announcement of drisapersen’s trial failure, were up 19 percent on Tuesday.

DOWNGRADES

Sarepta, previously known as AVI Biopharma, has gone more than three decades without bringing a drug to market. Analysts had previously said that they expected the company to ask for eteplirsen’s approval to be accelerated.

Sarepta said the FDA request would delay the initiation of dosing in a confirmatory study until at least the second quarter of 2014. A follow-up meeting with the regulator to discuss the confirmatory study design is scheduled this month.

“The likelihood of an accelerated approval at this point is very low. It seems like a long shot to me that the FDA is going to reverse position,” said Edward Tenthoff, analyst at Piper Jaffray.

Tenthoff, who cut his price target on the stock to $20 from $58, said he expected the FDA to require a confirmatory study with a two-year follow-up, which could delay the potential approval of eteplirsen to late 2017 or early 2018.

Both Tenthoff and Needham & Co’s Messer said the FDA and Sarepta would probably need to agree a new endpoint for trials, given the regulator’s concerns about the six-minute-walk trial.

“They thought they will be able to file early on limited data,” said Messer. “The FDA is not only saying forget about that, they probably also cannot do a full filing, and now it’s even questionable as to what the next study has to look like.”

Janney Capital Markets also downgraded Sarepta’s stock to “sell” from “neutral,” while Leerink Swann cut its price target to $17 from $44.

Sarepta’s shares were down 62 percent at $14.06 in early afternoon trading.

Source: Reuters

 

Mothers in UK offered Euro 200 for breastfeeding

breastfeedingNew mothers are to be offered up to £200 in shopping vouchers to encourage them to breastfeed their babies.

The pilot scheme is being targeted at deprived areas of South Yorkshire and Derbyshire and funded through collaboration between government and the medical research sector.

A third area is expected soon with the plan to trial it on 130 women who have babies from now until March.

If successful, a nationwide pilot could be rolled out in England next year.

The use of financial incentives is not new in the NHS.

It has been tried before to encourage people to quit smoking as well as lose weight.

Culture

But this is the first time it has been tried on such a scale for breastfeeding.

breastfeeding1

Under the scheme mothers from specific parts of Sheffield and Chesterfield will be offered the vouchers, which they can then use in supermarkets and high street shops.

The areas have been chosen because they have such low breastfeeding rates. On average just one in four mothers are breastfeeding by the six- to eight-week mark compared with a national average of 55%.

To qualify for the full £200 of rewards, the women will have to breastfeed until six months.

However, it will be frontloaded – enabling those taking part to get £120 for breastfeeding for the first six weeks.

Midwives and health visitors will be asked to verify whether the women are breastfeeding.

The team behind the project said breastfeeding was a cause of health inequalities, pointing to research that showed it helped prevent health problems such as upset stomachs and chest infections as well as leading to better educational attainment.Breastfeeding expert Geraldine Miskin Mums need to have practical advice

Dr Clare Relton, the Sheffield University expert leading the project, said she hoped the financial incentives would create a culture where breastfeeding was seen as the norm.

“It is a way of acknowledging both the value of breastfeeding to babies, mothers and society,” she added.

But Janet Fyle, of the Royal College of Midwives, questioned the initiative: “The motive for breastfeeding cannot be rooted by offering financial reward. It has to be something that a mother wants to do in the interest of the health and well-being of her child.”

She said the answer lay in making sure there was enough staff available to provide comprehensive support to new mothers after birth.

Source: BBC

Cancer Survivor to Return to Golf After 20 Months

When Jarrod Lyle returns to golf after a 20-month layoff at the Australian Masters, he expects some teary eyes on the tee.

Lyle is 32 years old and will be playing his first tournament since his second fight with myeloid leukemia — his first came at 17. This time, he’ll have his wife and young daughter with him Thursday when he starts a tournament that he’s not sure he’s physically ready to finish should he make the 36-hole cut.

“Just walking to that first tee and teeing the ball up and trying to hit it — that’s probably going to be the hardest thing,” Lyle said Tuesday at Royal Melbourne.

“It’s just going to let a whole lot of stuff out. Hopefully when that ball flies I can just get on to playing golf and put everything behind me and just get back to the golfer that I am.”

Lyle, then a regular on the U.S. PGA Tour, was diagnosed with his second bout of leukemia in March 2012 just before the birth of his daughter, Lusi. Lyle’s wife, Briony, became pregnant despite medical advice that Lyle’s first bout of cancer and the resulting chemotherapy would leave him sterile.

With a medical exemption to return to the PGA Tour whenever he feels he’s ready — and it might not be until late in 2014 — Lyle has found his second bout of cancer illuminating.

On the positive side, he knew what to expect, and anti-nausea drugs to counteract the chemotherapy had improved in the 15 years between his illnesses.

On the downside, because he had the disease once, it was harder to overcome twice. The first time, he spent two to three weeks at a stretch in the hospital. The second time, it often was four or five weeks or more. He’s lost weight, and his strength.

And he’s still not out of the usual five-year cancer-free time frame, as he thought he had done as a teenager.

Briony and Lusi, nearly 2, will be among a big group of friends and family supporting him at Royal Melbourne on Thursday on Friday. And against all odds, maybe the weekend.

Lyle will tee off just after midday on the first hole Thursday with two veterans to help him along — fellow Australian and 2006 U.S. Open champion Geoff Ogilvy, and Brendon de Jonge, the Zimbabwean who represented the International team at the recent Presidents Cup.

Many of Lyle’s fans will be wearing specially designed yellow shirts and hats to support his involvement in the children’s cancer charity Challenge.

When Tiger Woods won the Arnold Palmer Invitational at Bay Hill in 2012, he was wearing a “Leuk the Duck” pin on his cap. The cartoon duck is a mascot for kids who come through the Challenge charity, and Woods wore it out of respect for Lyle, as did many players in the field not long after Lyle’s second cancer fight was known.

“To have the support of all those guys, guys that I am not really close with as well, it is nice,” Lyle said at the time. “It is nice to know they still care and want to know how you are going.”

On Thursday, Lyle won’t forget that support and knows where his heart will be.

“I’m going to dedicate this first tee shot to everybody that’s done that over the years or over the last 20 months,” he said. “Everyone who has got in contact with us and given us support.”

Source: abc news

 

 

Health ‘score’ on food packages may help healthier choices

For people trying to wade though nutrition labels and choose healthy options, a front-of-package food label that boils down nutrition information to a single “score” may be the most user-friendly approach, a new study suggests.

In recent years, the fronts of some food packages have been decorated with short food labels, which are intended to briefly summarize a product’s nutrition, and make unhealthy ingredients (such as high levels of saturated fat) highly visible to consumers.

However, there is currently no standard for what information needs to be on these labels, leading to a variety of front-of-package food labeling systems that may confuse consumers, said study researcher Christina A. Roberto, a psychologist and epidemiologist at the Harvard School of Public Health.

Experts say that a single, uniform food label should be adopted, but before this can happen, researchers need to know what works best. The new study attempted to help answer this question by comparing five front-of-package food labeling systems, as well as packages with no label.

More than 1,000 people, about half of whom were actively trying to lose weight, were randomly assigned to view food products with one of the following labels:

A “Facts Up Front” label, which was created by the food industry and contains information about calories, saturated fat, sodium and sugars, as well as any noteworthy vitamins.

A “NuVal” label, a proprietary labeling system that gives products a score from 1 to 100 based on a product’s nutritional quality; higher scores denote healthier products.

A single traffic light symbol, which is colored red, yellow or green based on the healthfulness of the product.

A label depicting multiple “traffic lights,” in which different nutrients get their own red/yellow/green symbol (such as green for saturated fat, but yellow for sodium).

A star system, in which a product is given 0 to 3 stars based on its nutrition quality.

No label

In a simulated online shopping task, participants viewed different soups, cereals, beverages, rice products and ice creams, and were asked to choose which products they would like to eat this week.

The only food labeling system that prompted people to pick healthier soups was the NuVal label, the study found.

When shown two products and asked, “Which is healthier?” the NuVal label, along with the multiple traffic-light label, worked best to help participants identify which product was truly healthier.

However, those who viewed the NuVal label were able to choose the healthier product in half the time as those who viewed the multiple traffic-light label, Roberto said.

Based on these preliminary data, NuVal is probably “the most user-friendly,” Roberto said. The simplicity of the system (with just one number), and the fact that it allows users to compare products with high and low numbers, may be helpful to consumers, Roberto said.

However, much more research is needed to confirm the findings, including studies of “real-world” purchasing scenarios, Roberto said.

In addition, it’s not clear how much front-of-package labels help consumers overall. In the study, the food labels did not help consumers pick healthier cereals, beverages, rice products or ice creams.

However, Roberto argues these labels have a purpose.

“It might not massively shift behavior, but I think it’s still worth informing consumers,” Roberto said. “It might influence behavior some of the time, and that can still have an important and meaningful public health impact.”

And if front-of-package labels were mandatory — as proposed in a recent congressional bill — food companies may be pressured change their products so they are healthier (to get a higher NuVal score, or more “green” traffic lights, for instance).

If a uniform front-of-package label system is rolled out, consumers should be educated regarding how to interpret and use the labels, Roberto said.

The study was presented last week at the American Public Health Association meeting in Boston.

Source: Yahoo News

 

Brain stem abnormalities linked to SIDS, study shows

brain abnormaltiesUnderlying brain stem abnormalities may be responsible for the onset of sudden infant death syndrome (SIDS), a condition that causes babies to die unexpectedly in their sleep, Counsel and Heal reported.

In a study published in the journal Pediatrics, researchers reviewed the cases of 50 infants who died of SIDS. Though some of the infants studied were sleeping in unsafe environments – such as in a face-down position– the researchers discovered that regardless of sleep conditions, all of the babies studied showed abnormalities in their brain stem chemicals.

The researchers believe that these abnormalities prevented the infants from waking up when they experienced trouble breathing. However, the researchers said parents should still make every effort to ensure that their infants sleep in a safe environment.

“We have to find ways to test for this underlying vulnerability in living babies and then to treat it. Our team is focused now upon developing such a test and treatment,” said study author Dr. Hannah Kinney, a neuropathologist at Boston Children’s Hospital. “Safe sleep practices absolutely remain important, so these infants are not put in a potentially asphyxiating situation that they cannot respond to.”

Source: News.nom

Myth or fact? Coconut oil helps treat Alzheimer’s disease

With more than 5 million Americans suffering from Alzheimer’s disease, many people are looking to alternative treatments for help.

We received this email from a concerned viewer:
Dear Dr. Manny,
Does coconut oil help prevent Alzheimer’s disease?
Thanks,
Darrell

Processing coconut oil produces a kind of fat called caprylic acid, which the body then breaks down into substances called ketone bodies.

The theory behind using coconut oil for the prevention or treatment of Alzheimer’s disease is that these ketone bodies can provide an alternative source of energy to brain cells that have lost their ability to use glucose as a result of the disease.

“There was one study that seems to have sparked sort of a firestorm of hope,” said Chris Kilham, the Medicine Hunter. “That was a test-tube study, showing a change in the behavior of beta-amyloid plaque cells – which are the same kinds of cells that accumulate in the brainstem during Alzheimer’s – when they were exposed to ketones derived from coconut oil.”

Kilham said that researchers at the University of South Florida Health Byrd Alzheimer’s Institute are currently studying the effects of coconut oil on a small group of Alzheimer’s patients in a first-of-its-kind clinical trial. But he added that at this point in time, there is no science to back up the claims that coconut oil is beneficial for Alzheimer’s disease.

“It may be in fact beneficial, but we don’t know that yet,” said Kilham. “There are some anecdotal studies, people who say that partners of theirs have started taking …virgin coconut oil daily, and they’ve improved. This may be so, but right now, today, I don’t want to give out false hope. There’s no good science on this, and until there is, I’m holding off making a recommendation.”

Currently, there is no cure for Alzheimer’s disease, but there are treatments that may help with both cognitive and behavioral symptoms to improve a patient’s quality of life.

Source: Fox news

 

FDA Takes Two Important Actions on Drug Shortages

The U.S. Food and Drug Administration is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. Following the President’s 2011 Executive Order on reducing drug shortages, the number of new shortages in 2012 was 117, down from 251 in 2011.

Today’s announcements build on this work. First, the FDA is releasing a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the agency’s response to imminent or existing shortages, and for longer term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing.

Second, the FDA issued a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply. The rule also extends this requirement to manufacturers of medically important biologic products. The proposed rule implements the expanded early notification requirements included in FDASIA.

“The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders.”

Early notification gives the FDA time to:

  • work with manufacturers to investigate the issue leading to the manufacturing disruption;
  • identify other manufacturers who can make up all or part of the shortfall; and
  • expedite inspections and reviews of submissions from manufacturers of drugs that may prevent or mitigate a shortage.

Early notification from manufacturers about possible shortages, as requested in the President’s Executive Order 13588 of Oct. 31, 2011 and then codified into law in FDASIA, has enabled the FDA to work with manufacturers to restore production of many lifesaving therapies. Since the Executive Order, there has been a 6-fold increase in notifications to the FDA.

The notifications received under the existing requirements have resulted in real progress in addressing shortages. The FDA helped prevent 195 drug shortages in 2011 and 282 drug shortages in 2012, leading to a reduced number of new shortages in 2012. The expanded early notification requirements would further enhance the FDA’s ability to address issues prior to the occurrence of a shortage.

The strategic plan, which was required by FDASIA and is being sent to Congress today, describes actions the FDA will undertake to improve its current efforts to respond to early notifications of a potential shortage. These include:

  • improving the FDA’s communications about shortages, such as launching a new mobile app, so that individuals can instantaneously access drug shortage information via their smart phones;
  • clarifying manufacturers’ roles and responsibilities by encouraging them to engage in certain practices that will reduce the likelihood of a shortage; and
  • updating the FDA’s internal procedures for responding to early notifications of potential shortages.

The strategic plan also describes efforts the FDA is considering to address the manufacturing and quality issues that are most often the root cause of drug shortages. These include:

  • broader use of manufacturing metrics to assist in the evaluation of manufacturing quality, as well as incentives for high-quality manufacturing;
  • internal organization improvements to focus on quality, including a proposed Office of Pharmaceutical Quality within CDER; and
  • Risk-based approaches to identify early warning signals for manufacturing and quality problems.

Source: drugs

Deadly MERS virus found in Saudi Arabian camel

The Saudi Health Ministry says it has discovered a deadly virus in a camel in Jiddah province, on the western coast of Saudi Arabia.

The ministry’s statement released Monday is considered an important development in the search for the origin the deadly illness. There have been more than 60 deaths from the virus known as Middle East respiratory syndrome, or MERS, with all but a handful of the fatalities in Saudi Arabia.

The ministry said a sample from the camel was tested near the home of a patient infected with the virus.

An international research team in August found the mysterious virus that is related to SARS in a bat in Saudi Arabia. They suspected it was perhaps another animal that was spreading the virus directly to humans.

Source: The New Zealand Herald

Link Between Diabetes and Osteoporosis

What is the link between diabetes (both type 1 and type 2) and bone mineral density/osteoporosis in postmenopausal women?

Ashraf Kardousha, MD

Adult women with type 1 diabetes have relatively decreased bone mass, increased fracture risk, and delayed fracture healing compared with healthy women without diabetes. In addition, researchers have show that the biomechanical integrity of diabetic bone may be impaired. However, patients with type 2 diabetes usually do not have a decreased bone mass and, in fact, may be relatively protected from osteoporosis.

Early onset of diabetes, in particular, is associated with reduced bone density, and patients with type 1 diabetes show evidence of low bone mass following adolescence. This finding may explain the higher incidence of hip fracture reported for postmenopausal women with type 1 diabetes. The osteopenia associated with diabetes appears to be associated with a decreased bone turnover associated with impaired osteoblastic maturation and function. This is reflected in a decrease in serum markers of bone formation, such as osteocalcin. Bone resorption and formation are usually tightly coupled, but this has not been well studied in patients with diabetes. The few available studies suggest that the rate of bone resorption in diabetes is normal and therefore elevated relative to the decreased rate of bone formation. Evidence that there are significant alterations in serum parathyroid hormone levels or function is lacking. Boullion and colleagues[3] showed reduced serum levels of insulin-like growth factor 1 (IGF-1), osteocalcin, and bone-specific alkaline phosphatase in adolescents with type 1 diabetes, but not all markers were reduced in adults. Studies in diabetic animals show that there is enhanced apoptosis of osteoblastic cells and, although there is sufficient production of immature mesenchymal tissue, there is failure to adequately express genes that regulate osteoblast differentiation.

In contrast to findings in type 1 diabetes, patients with type 2 diabetes do not have low bone mass and may be relatively protected from osteoporosis. It is not known whether adolescents with type 2 diabetes will demonstrate a low bone mass. However, it is hypothesized that this is unlikely since most of these children are also obese. Our own studies in type 2 diabetes show that, while bone turnover is suppressed in patients in poor glycemic control, bone metabolism returns to normal with normalization of glycemia. Recent studies suggest that a negative correlation may exist between levels of osteocalcin and glycemic control. It is not clear if hyperglycemia per se is responsible or if the associated absolute or relative insulin deficiency might be involved. Bone cells have receptors for both insulin and IGF-1, and in vitro insulin has been shown to increase proliferation and function of osteoblasts. In animals, insulin deficiency suppresses osteoblastic activity. Levels of IGF-1 tend to be low in patients with poorly controlled diabetes mellitus and improve with improving glycemic control. A correlation between IGF-1 and osteocalcin levels has been shown for both type 1 and type 2 patients, and IGF-1 has been shown to stimulate osteoblastic differentiation, maturation, and function.

The difference in bone loss between the 2 forms of diabetes is often attributed to the degree of adiposity. Increased body weight has been associated with an increased bone mass in both normal and diabetic individuals, and may account for the relative protection seen in patients with type 2 disease. In addition to the mechanical effects of increased weight bearing, many women who are obese and relatively insulin-resistant have elevated levels of androgens, which may contribute to bone maintenance. In addition, it is not clear whether bone cells are insulin-resistant, similar to other tissues in type 2 diabetes. If not, then high circulating insulin levels could be expected to increase osteoblast function and have a beneficial effect on bone mass. It has been suggested that hyperinsulinemia may be partially responsible for the association of both diabetes and obesity with a higher BMD in women. It should be noted that there is some evidence of higher fracture risk in type 2 patients despite normal bone mass. Other factors, such as neuropathy and impaired vision, may contribute to the increased fracture risk.

Type 1 diabetes does appear to be a significant risk factor for osteoporosis. Currently, we recommend that patients with type 1 diabetes be monitored more carefully than persons without diabetes or those with type 2 disease, and should be encouraged to consume a diet high in both calcium (at least 1200 mg/day) and vitamin D (400-600 IU/day). It appears that intensive insulin therapy and a stable body weight in patients with type 1 diabetes is important in preventing bone loss. Patients with diabetes and osteopenia or osteoporosis have successfully been treated with bisphosphonates, with similar bone density results as patients without diabetes. Due to impaired osteoblast function, patients with diabetes might be expected to benefit more from bone anabolic (rather than anti-resorptive) medications, but this has yet to be demonstrated in a clinical trial.

For patients with type 2 diabetes who are in good metabolic control, prevention and treatment of osteoporosis can be approached in a manner similar to patients without diabetes as outlined in the National Osteoporosis Foundation (NOF 2003) physician guidelines.

Source: Med Scape

 

GlaxoSmithKline heart drug misses goal in major study

An experimental GlaxoSmithKline drug, designed to fight heart disease in a new way, failed to meet its main goal in a major late-stage clinical study, dealing a blow to one of the company’s biggest new treatment hopes.

Darapladib’s inability to reduce the overall risk of heart attacks and strokes in the first of two big Phase III studies is disappointing, but not a huge surprise. Many analysts already had low expectations for the project.

Shares in Britain’s biggest drugmaker had fallen 1.2 percent on the news by 1050 GMT on Tuesday, and Deutsche Bank analyst Mark Clark said failure of the drug removed some “blue sky fantasy” about potential multibillion-dollar sales.

GSK obtained full rights to darapladib, along with lupus drug Benlysta, when it bought U.S. biotech firm Human Genome Sciences last year for $3 billion.

The once-daily pill did produce statistically significant reductions in serious coronary events in some of the pre-defined secondary endpoints of the trial, which GSK said required more analysis.

Darapladib is designed to prevent heart attacks and strokes in a completely different way from cholesterol-lowering statin drugs by targeting an enzyme called Lp-PLA2 that is linked to artery-clogging plaques.

While some industry analysts have suggested it could become a $10 billion-a-year seller, if it works, few have pencilled in significant sales forecasts so far, given uncertainty about the product.

Current consensus forecasts point to annual sales of only $605 million in 2018, according to Thomson Reuters Pharma.

Panmure Gordon downgraded GSK shares to “hold” from “buy” on the latest news, which it said was the second big disappointment in the year, following similarly negative results with the company’s MAGE-A3 cancer vaccine for melanoma in September.

It also predicted GSK would write down 150 million pounds ($240 million) of its investment in darapladib in the fourth quarter, even though a second Phase III trial is continuing.

“Even if that trial was successful, we believe it will be difficult to gain market registration on one trial alone,” said Panmure analyst Savvas Neophytou.

Patrick Vallance, GSK’s head of pharmaceuticals R&D, said the group would continue to investigate the role of Lp-PLA2 inhibition in coronary heart disease and other conditions, while also poring over the latest trial results.

“We will now work to better understand the data, including evaluation of the patient sub-groups, and await the outcome of a second Phase III study of darapladib in acute coronary syndrome,” he said in a statement.

The first trial, known as STABILITY, enrolled nearly 16,000 patients with chronic coronary heart disease in 39 countries and measured the differences in outcomes between giving them darapladib or a placebo pill, in addition to standard drugs such as statins, aspirin and blood pressure medicines.

A second 13,000-patient study, called SOLID-TIMI 52, is due to complete in March 2014 and is looking at patients who have already suffered an acute coronary event. It will assess if darapladib can prevent a secondary attack.

Some medical experts believe darapladib may have a better chance of success in the second study.

GSK has had some notable successes with its new drugs this year, including approvals of medicines for cancer, lung disease and HIV. But its failure to deliver positive results in more ambitious projects like darapladib and MAGE-A3 may cast doubt over its prowess in the most cutting-edge science.

Source: Zee News