Once Avandia's heart risks were fully understood, the former blockbuster from GlaxoSmithKline ($GSK),
was tightly restricted in the U.S. and pulled from the European market.
The diabetes drug was at the heart of the company's $3 billion
settlement with federal authorities last year. Now, the FDA will take
another hard look at research on its side effects to see if there is something more the agency should do to limit its use.
An
FDA advisory meeting is slated to meet for two days in June to
re-analyze the 2009 RECORD study which found that rosiglitazone doubled
the heart risks of patients. The agency is concerned about how the first
study was designed and handled, Morgan Liscinsky, an FDA spokeswoman,
told Bloomberg. Based on the new review, the agency could change the way it handles the drug, she said.
GSK spokeswoman Mary Anne Rhyne said the company stands behind the safety and effectiveness of Avandia when it is used according to its label. She said the drugmaker is not seeking any new uses.
The second review is unusual given how few patients can get the drug, leading Washington Analysis analyst Ira Loss to speculate to Bloomberg that the agency must be looking for a reason to pull the drug from the market altogether. Why else, Loss said, would the FDA be "wasting two days of an advisory committee meeting. It's sort of like beating a dead horse."
Researchers did recently find that rosiglitazone provided some improvement in memory during preclinical testing for use as an Alzheimer's treatment, and said they were ready to start clinical trials on similar drugs.
Avandia sales peaked at about $2 billion a year before the FDA in 2010 put tight restrictions on its use. Authorities in Europe ordered it removed from the market because of elevated risks of heart attack. The company took a $2.4 billion charge that year to cover litigation. GSK pleaded guilty to three misdemeanor charges last year as part of its record-breaking settlement with the Department of Justice. It also has settled 20,000 Avandia cases through mediation.
SOURCE : http://www.fiercepharma.com/story/fda-taking-new-look-avandia-risks/2013-04-15
An
FDA advisory meeting is slated to meet for two days in June to
re-analyze the 2009 RECORD study which found that rosiglitazone doubled
the heart risks of patients. The agency is concerned about how the first
study was designed and handled, Morgan Liscinsky, an FDA spokeswoman,
told Bloomberg. Based on the new review, the agency could change the way it handles the drug, she said.GSK spokeswoman Mary Anne Rhyne said the company stands behind the safety and effectiveness of Avandia when it is used according to its label. She said the drugmaker is not seeking any new uses.
The second review is unusual given how few patients can get the drug, leading Washington Analysis analyst Ira Loss to speculate to Bloomberg that the agency must be looking for a reason to pull the drug from the market altogether. Why else, Loss said, would the FDA be "wasting two days of an advisory committee meeting. It's sort of like beating a dead horse."
Researchers did recently find that rosiglitazone provided some improvement in memory during preclinical testing for use as an Alzheimer's treatment, and said they were ready to start clinical trials on similar drugs.
Avandia sales peaked at about $2 billion a year before the FDA in 2010 put tight restrictions on its use. Authorities in Europe ordered it removed from the market because of elevated risks of heart attack. The company took a $2.4 billion charge that year to cover litigation. GSK pleaded guilty to three misdemeanor charges last year as part of its record-breaking settlement with the Department of Justice. It also has settled 20,000 Avandia cases through mediation.
SOURCE : http://www.fiercepharma.com/story/fda-taking-new-look-avandia-risks/2013-04-15
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