Once the world’s best-selling treatment for type 2 diabetes, GlaxoSmithKine’s Avandia is currently banned in Europe and severely restricted in the U.S – due to an increased risk of heart attack and stroke. But new recommendations from federal health advisors may change things. The New York Times reports, “A panel of experts voted Thursday to loosen restrictions [on Avandia], saying doctors should have more freedom to prescribe it to patients.”
The Food and Drug Administration advisory panel’s members voted after a two-day meeting to consider a new analysis of Avandia’s cardiovascular safety. Of the 26 members in attendance, 13 voted to relax safety restrictions, 7 voted to remove restrictions, 5 to keep them the same, and one panelist voted to withdraw Avandia from the market altogether.
Too little, too late
Even if the FDA does loosen restrictions, it may be too late for Glaxo. According to CNBC, panel members agreed that Avandia may never reach its former annual sales of $3.2 billion. “The train has left the station,” said Gerald van Belle, director of the Clinical Trials Center at the University of Washington. Glaxo’s patent on Avandia expired last year. Although another drug company has approval to sell a generic version, it has not done so.
Glaxo has settled a myriad of lawsuits filed by “tens of thousands” of patients who claim Glaxo failed to inform them about safety risks. And, in an unprecedented case last summer, the drugmaker agreed to pay $3 billion to settle the largest case of healthcare fraud in U.S. history – resolving allegations that they had failed to provide safety data on Avandia to the FDA and had improperly marketed other drugs.
In a statement, Glaxo said it would work with the FDA as it considers any potential changes. Currently, Avandia may only be prescribed as a last resort to those who have not responded to other therapies – about 3000 patients, down from 120,000 before restrictions were put in place. The panel’s recommendation is not binding, but the FDA will take it into consideration when it makes its final decision, no word yet on when that will be.
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