The FDA needs some time to think about Avandia safety–and apparently so do European regulators. This week the European Medicines Agency was expected to entertain recommendations on future use of the controversial GlaxoSmithKline diabetes drug. But the EMA Committee for Medicinal Products for Human Use (CHMP) said it needs to keep weighing the data.

Now, CHMP says it will wrap up its review of the Avandia evidence by September. “The committee noted that additional new data sets have become available very recently,” EMA said in a statement. In the meantime, the agency is advising doctors to “strictly follow” Avandia’s labeling.

At least some of that new data–if not all–would have been reviewed already by FDA’s expert advisors for last week’s high-profile meeting on the drug. That panel essentially voted to keep Avandia on the market, but with additional warnings and/or restrictions.

FDA itself is now deciding exactly what to do, and as was apparent during the committee meeting, agency staff is far from united in its approach to Avandia. The agency says it’s going to deliver a verdict as soon as possible.

Source: FiercePharma

Popularity: 1% [?]

European health regulators recommended on Thursday restricting the use of Cephalon’s sleep disorder drug Provigil for treating narcolepsy only, over concerns that risks may outweigh the benefits of the medicine in other uses.

The European Medicines Agency said doctors and patients should no longer use medicines that contain modafinil — the active ingredient in Provigil — for sleep apnea, chronic shift work sleep disorder or other previously approved uses.

Cephalon, whose shares fell nearly 2 percent, said it will request a re-examination of the agency’s assessment.

Analysts said any damage from new Provigil restrictions in Europe should be limited.

The “recommendation to restrict the use of Provigil in Europe will have a minimal impact on earnings,” Louise Chen, an analyst for Collins Stewart, said in a research note.

Robert W Baird analyst Thomas Russo said he still expects Cephalon to raise its full year forecast when it reports second-quarter earnings next week due to growth of the cancer drug Treanda and U.S. price increases on Provigil.

A review of the drug was initiated by European regulators over a number of safety concerns related to psychiatric disorders, skin and subcutaneous tissue reactions as well as significant off-label use and potential for abuse, the agency said.

On the basis of the available data the agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the drug only outweighs the risks in the treatment of narcolepsy, a chronic sleep disorder characterized by excessive daytime sleepiness.

Narcolepsy was the original use for which Provigil was approved.

For all other uses European officials said safety risks outweighed evidence of clinical efficacy.

The CHMP also identified particular cardiovascular risks with modafinil and recommended that it not be prescribed to patients with uncontrolled high blood pressure or irregular heart rhythms.

“Modafinil has been used safely and effectively for its licensed indications in Europe for many years and we believe the risk/benefit profile in all approved indications is positive,” Cephalon spokeswoman Candace Steele Flippin said.

Modafinil is currently licensed in 21 countries in Europe.

Cephalon shares closed down $1.14, or 1.9 percent, at $59.89 on Nasdaq.

Source: Reuters

Popularity: 2% [?]

GlaxoSmithKline Plc’s diabetes pill Avandia came under intense scrutiny on both sides of the Atlantic on Friday, leaving the drug’s future uncertain as its maker battles a wave of lawsuits.

In London, the European Medicines Agency (EMA) launched a new review into Avandia’s risks and benefits, adding to pressure on a product that faces a grilling from U.S. experts next week over its cardiovascular safety.

Scientists within the U.S. Food and Drug Administration are deeply divided over Avandia’s heart risks amid conflicting data, according to more than 700 pages of documents prepared for the July 13-14 advisory panel meeting.

The FDA and EMA will consider a range of options, including whether the medicine should be pulled from the market.

Some doctors want to keep Avandia as a possible treatment for lowering blood sugar for people who are not helped by other medicines for diabetes, a disease that causes heart disease, blindness and other complications.

But critics, including some FDA staff, say diabetics have plenty of alternatives and Avandia should be banned.

The pill was once Glaxo’s second-biggest drug but its sales have plunged since safety fears erupted three years ago. Revenues totaled 771 million pounds ($1.17 billion) in 2009, equivalent to 2.7 percent of Glaxo’s group sales.

The big worry for investors, though, is litigation.

Concerns about the medicine’s adverse impact on the heart have triggered a slew of lawsuits in the United States and fresh criticism of the drug from regulators is likely to make matters worse by playing into the hands of plaintiff lawyers.

Glaxo has vigorously defended the medicine, based in part on a study called Record that the British drugmaker said found no higher rates of heart-related hospitalizations or deaths.

An FDA cardiology expert sharply criticized the study in a memo prepared for the advisory panel.

The trial “was inadequately designed and conducted to provide any reassurance about” the cardiovascular risks of Avandia, wrote Dr. Thomas Marciniak, a medical team leader in the FDA division that reviews heart drugs.

But Dr. Ellis Unger, a deputy director in FDA’s drugs center, said “aside from the known risk of heart failure, the study does not appear to demonstrate harm” from Avandia. The drug’s warning label already warns about heart failure risk.

Glaxo’s European medical director, Tony Hoos, said Avandia was “an important treatment option for appropriate Type 2 diabetes patients.”

The company said overall data, including six clinical trials, showed Avandia does not increase the risk of heart attack, stroke or death. The medicine also is the only oral anti-diabetes drug that has been shown to control blood sugar for up to five years, Glaxo said.

The FDA usually follows recommendations from its advisory panels but is not required to.

Glaxo shares closed Friday just 0.2 percent lower on the New York Stock Exchange after closing unchanged in London, where they recovered from being down as much as 2.6 percent.

OUTSPOKEN CRITICS

Persuading doctors and patients of the drug’s benefits is becoming an uphill battle, with two recent negative studies.

In one study, Dr. Steven Nissen, a cardiologist at Ohio’s Cleveland Clinic and an outspoken Avandia critic, offered more ammunition to his 2007 analysis that first suggested Avandia raises heart risks.

In the second, FDA reviewer David Graham found Avandia was more dangerous to the heart than a competitor, Takeda Pharmaceutical Co’s Actos.

Both Graham and Nissen believe the drug is too risky to stay on the market and will speak to the panel.

Ambrian Partners analyst Mike Ward said “the ultimate downside would be a panel recommendation for Avandia’s withdrawal, which FDA would not have to act upon but probably would, given the politics of the situation.”

“More likely, is yet further tightening of Avandia’s label or maybe a restriction on its use to patients failing on Actos therapy,” Ward said.

FDA staff will present results of an analysis comparing Avandia with Actos at next week’s meeting.

A review of several clinical trials found heart attacks, strokes or related deaths were lower for Actos compared with other diabetes drugs or a placebo. FDA staff added, however, that differences in study design limited their ability to directly compare the drugs.

The FDA is turning to the advisory panel to help sort out the mixed data.

“There is not complete unanimity within the FDA about the interpretation of these data,” Dr. Janet Woodcock, head of the FDA’s drugs center, told reporters.

A current trial called Tide was designed to test Avandia directly against Actos. Critics who see Actos as safer have called the study unethical. The FDA will ask the advisory panel if the study should continue.

TEST OF FDA

The Avandia controversy is seen as a test for the FDA under Democratic President Barack Obama and his chosen leader, Commissioner Margaret Hamburg. Doctors, drugmakers, investors and patient advocates are closely watching the decision as a sign of how the agency will handle future medicines.

Concerns have dogged Avandia since 2007 when Cleveland Clinic researchers linked the pill to a higher heart-attack risk. An advisory panel that year agreed the data suggested Avandia may increase the chances of a heart attack for some patients but said the medicine should remain an option.

European regulators have also concluded in a number of previous reviews — the last of which was early this year — that the overall risk-to-benefit balance was favorable.

But that verdict may not last and the EMA said it would decide once relevant data was analyzed if Avandia’s marketing authorization should be revoked, suspended or changed.

Experts from the agency’s Committee for Medicinal Products for Human Use will discuss the issue at their next plenary meeting in London on July 19-22.

Source: Reuters

Popularity: 3% [?]

We like taking potshots at Big Pharma, and often deservedly so. But critics may take a break when they consider the recent move by a dozen competing drug companies, which have agreed to share data on thousands of Alzheimer’s patients who participated in failed clinical trials. The idea behind the move is that the shared data will help accelerate new treatment research on brain diseases.

Alzheimer’s disease is a progressive, incurable and fatal brain disease that destroys brain cells, causing memory loss and problems with thinking and behavior severe enough to affect all aspects of life.

Roughly 6.5 million people in the U.S. are afflicted with Alzheimer’s and Parkinson’s diseases, with costs reaching as much as $175 billion annually. The number of those afflicted is growing as the population ages.

Challenging Scientific Research

Alzheimer’s has been a particularly tough area of research, with little to show for the millions spent. Just in March, Johnson & Johnson pushed back results from a much anticipated Alzheimer’s trial to 2012, and Medivation’s and Pfizer’s late-stage trial for the Alzheimer’s drug Dimebon failed to hit its efficacy goals.

Not only that, but over the past few months, some new research has suggested that drugs being investigated for Alzheimer’s disease may be causing further neural degeneration and cell death. The new theory is that brain plaque has a protective role, rather than a destructive one, which would explain the failure of so many drugs.

With the National Institutes of Health concluding that none of the methods attempted to prevent, delay or reduce the severity of Alzheimer’s disease have proved to work, and with no treatment progress to speak of, the situation seems bleak.

Sharing Failed Drug Trials Data

A new database may offer some hope. In it, data on more than 4,000 Alzheimer’s patients who have participated in 11 industry-sponsored clinical trials of failed drug candidates will be released by the Coalition Against Major Diseases (CAMD). The database will be shared by pharmaceutical companies and researchers around the world in the hopes it will assist in making progress against Alzheimer’s, Parkinson’s, Huntington’s and other neuro-degenerative diseases.

Of course, still unable to take the leap to full transparency, the secretive pharmaceuticals will only share data on those patients in the placebo arm, the Financial Times reported. Still, the data should help provide researchers with valuable information, especially in developing biomarkers, or biological measurements that can be used to assess progress in tackling Alzheimer’s. The shared data will be detailed, including memory tests, brain scans and blood samples, the Associated Press reported.

“Companies said they’re running into a stone wall with Alzheimer’s and Parkinson’s,” Ray Woosley, chief executive of the Critical Path Institute, told The Wall Street Journal. “We really believe drugs are failing because we honestly don’t understand the disease.” The data could help researchers find meaningful trends that may suggest what to study next.

While it’s no doubt going to be difficult to comb through the data, it’s better than not being able to access the data at all. And perhaps no less important, it could improve the industry’s R&D productivity as they lessen duplicate failed efforts.

The CAMD database will also allow researchers to design more efficient clinical trials. The pharmaceutical members have also agreed to use the new standard in their future submissions for drug approvals, making the FDA’s review process more efficient.

Pharmaceuticals, Government, Research and Patient Groups Collaborate

The effort is supported by the U.S. Food and Drug Administration and includes advisers such as the European Medicines Agency, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging. CAMD is led and managed by the non-profit Critical Path Institute, or C-Path.

Among members of CAMD are such pharmaceutical giants as AstraZeneca, Roche’s Genentech, GlaxoSmithKline, Abbott, Sanofi-Aventis, Novartis, Eli Lilly, J&J and Pfizer. The coalition also includes research foundations and patient advocacy groups such as the Alliance for Aging Research, Alzheimer’s Association and Alzheimer’s Foundation of America, among others.

Alzheimer’s disease afflicts 30 million people worldwide, a number that may exceed 100 million by 2050, according to Alzheimer’s Disease International.

Source: DailyFinance

Popularity: 7% [?]

Major drugmakers will share data from their clinical trials for Alzheimer’s and Parkinson’s disease in an effort to speed the development of new medicines to treat the brain disorders.

The database, a public/private partnership to be announced on Friday, will give academic and industry researchers worldwide access to information from more than 4,000 patients with neurodegenerative diseases.

Bringing the data together, rather than keeping pieces of it within each drug company, will give scientists a larger amount of information on how the diseases progress and how they differ in various patients.

Backers hope the approach will jump start research into treatments for some of the toughest and most common brain disorders. Despite decades of study, doctors still have few effective treatments for Alzheimer’s disease, which affects more than 26 million people globally. It is the most common form of dementia.

An estimated four million people worldwide have Parkinson’s disease, which causes trembling and other symptoms.

Information in the new database should help drugmakers design more efficient clinical trials of potential treatments, said Dr. Raymond Woosley, president and chief executive of the Critical Path Institute, a nonprofit organization working to improve drug development.

Some patients, for example, develop Alzheimer’s in their 80s while for others it starts in their 40s, Woosley said. The disease probably evolves differently in those groups, but companies only have small numbers in each age range to study in their own trials.

“If you have 4,000 patients (in the database), you begin to have enough data to see their real course” and can target a drug to specific types of patients, Woosley said in an interview.

The database is coordinated by the Coalition Against Major Diseases, an organization of patient groups and 13 drugmakers that is part of the Critical Path Institute.

Companies in the coalition include Pfizer Inc, GlaxoSmithKline PLC, Johnson & Johnson and Sanofi-Aventis.

Officials from the Food and Drug Administration, the National Institutes of Health and the European Medicines Agency serve as advisers.

Source: Reuters

Popularity: 5% [?]

GlaxoSmithKline (GSK) confirmed that following a meeting of the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency (EMA) has maintained its position that there is no evidence that the presence of porcine circovirus (PCV) in Rotarix™ presents a risk to public health and that there is no need to restrict its use in the European Union. This announcement is in line with the assessment of the US Food and Drug Administration earlier this month which stated that the benefits of the rotavirus vaccines are substantial, and include prevention of death in some parts of the world and hospitalisation for severe rotavirus disease in the United States.

Thomas Breuer, Head of Global Development, GSK Biologicals said: “The announcement today by the EMA is further confirmation that the benefit/risk profile of Rotarix remains positive and unchanged. The availability of rotavirus vaccines is critical from a public health perspective and GSK is dedicated to continuing to work with the EMA and other regulatory agencies around the world to help protect to children from rotavirus disease.”

Rotavirus is the leading cause of severe gastroenteritis among children below five years of age. It is estimated that more than half a million children die of rotavirus gastroenteritis each year, a child a minute worldwide.(1,2) It is predicted that rotavirus vaccination could prevent more than 2 million rotavirus deaths globally over the next decade.(3) A randomised, double-blind, placebo-controlled study conducted in six European countries (Czech Republic, Finland, France, Germany, Italy and Spain) demonstrated that, during the first year of life, the efficacy of Rotarix against severe rotavirus gastroenteritis (RVGE) was 96% (95.8%) and against hospitalisation due to RVGE was 100%.(4,5).

Source: World Pharma News

Popularity: 2% [?]

Nycomed’s COPD drug Daxas may be in deep trouble in the U.S., but a thumb’s up from the European Medicines Agency last week set the stage for a new co-promotion deal with Merck covering the continent and Canada.

An FDA panel voted not to recommend the therapy for approval a little more than two weeks ago. That was a heavy blow for Switzerland’s Nycomed–which has been grooming itself for an IPO–and its U.S. partner Forest Laboratories. The developer, though, gets an undisclosed upfront payment in the deal to co-promote in France, Germany, Italy, Spain, Portugal and Canada.

“This builds upon Merck’s leadership in the asthma and allergy marketplace and positions the company to leverage our well-trained sales force to target the rapidly growing unmet medical need of COPD,” said Kevin Ali, a senior VP at Merck.

Nycomed’s crucial presentation to an FDA expert panel earlier this month foundered on a belief by a majority of the panel that the data on Daxas demonstrated too few benefits and too many potential safety issues to warrant an approval. A company spokesperson told Reuters that Nycomed is still planning an IPO “sooner or later,” which sheds as little light on those plans as the co-promotion announcement did on the financials in the Merck deal.

Source: FIerceBiotech

Popularity: 2% [?]

Nycomed is in luck. The European Medicines Agency today recommended approval of Daxas, the company’s once-a-day pill for patients with severe COPD. The approval follows an expert FDA panel’s decision earlier this month not to recommend the drug for approval. In a 10-5 vote, panelists determined the side effects of Daxas outweighed the limited improvement in lung function. The ruling was a blow to Nycomed’s partner Forest Labs, which has U.S. rights to Daxas. A final FDA decision is due in May.

Nycomed says it will launch Daxas later this year once it obtains a formal approval from the European Commission. The drug’s approval there could lead to an IPO for Nycomed, which has planned to go public but never provided a timetable for doing so. “Nycomed is excited about the positive opinion of the CHMP recommending approval of Daxas in the European Union. Daxas is the first in a new class of oral agents to treat this life-threatening condition, offering clinicians and patients a much needed new treatment option alongside existing inhaled therapies,” said Anders Ullman, Nycomed executive vice president of R&D.

Source: FierceBiotech

Popularity: 2% [?]

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arzerra, a treatment for chronic lymphocytic leukemia, which is a cancer of the blood and bone marrow. The CHMP has recommended the drug for patients whose disease continues to progress despite receiving fludarabine and alemtuzumab, the current standard of care.

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Arzerra is also undergoing clinical trials for rheumatoid arthritis. It was also in testing for non-Hodgkin’s lymphoma, but produced underwhelming results for that indication. The treatment was approved by U.S. regulators just a few months ago. GSK licensed the drug, also known as ofatumumab or HuMax CD-20, in 2007 for $2.1 billion.

Source: FierceBiotech

Popularity: 5% [?]

The European Medicines Agency has recommended to the European Commission that an additional vaccine against influenza A(H1N1) (’swine flu’), Celvapan from Baxter, be granted a marketing authorisation. Adoption of an authorisation decision by the European Commission is expected shortly. This recommendation follows the authorisation of Focetria, from Novartis, and Pandemrix, from GlaxoSmithKline, by the European Commission on 29 September 2009.

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As for Focetria and Pandemrix, this recommendation will allow the manufacturer to replace the flu virus strain in the current ‘mock-up’ vaccine with the A(H1N1)v strain causing the current pandemic.

Celvapan is a non-adjuvanted vaccine. This means that it does not contain ‘adjuvants’ to enhance the immune response. The Committee for Medicinal Products for Human Use (CHMP) is currently recommending a two-dose vaccination schedule, at an interval of three weeks, for adults, including pregnant women, and for children from six months of age. Clinical trials in adults and in children are ongoing, and more results will become available from mid-October 2009 onwards.

Vaccination strategies are decided by the government in each European Union (EU) Member State, taking the information provided by the Agency for each pandemic vaccine into account.

As with all medicines, rare adverse reactions may only be detected once the vaccine is being used in large numbers of people. The Agency has requested that Baxter implement the same plans as for the other pandemic vaccines, to actively investigate and monitor the safety of Celvapan as soon as it is being used across the EU, so that action can be taken as early as possible if a safety issue emerges. As part of this, the manufacturer has committed to carry out post-authorisation safety studies in about 9,000 subjects.

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The Committee will continue to evaluate all information that becomes available, and make further recommendations if necessary, to ensure that the benefits of all pandemic vaccines outweigh their risks, taking into account the spread and severity of the pandemic.

Other applications for marketing authorisations for pandemic vaccines are still under review.

Source: PHARMANEWS.EU

Popularity: 4% [?]