F.D.A. Panel Recommends Approval of a Gout Drug
UPDATE: A federal advisory committee on Tuesday recommended approval of a drug developed by Savient Pharmaceuticals to treat severe cases of gout. The Advisory Committee’s recommendation, although not binding, will be considered by the FDA in its review of the Biologics License Application that Savient has submitted for Krystexxa. The FDA usually follows the advice of its advisory committees.
The 14-to-1 vote for approval reflected a general consensus that the effectiveness of the drug in relieving severe pain and disability outweighed the risk of allergic reactions and suggestions that it could cause cardiovascular problems.
Gout is an exceedingly painful form of arthritis that afflicts the big toe and other joints. It is estimated that two million to six million Americans have gout. Krystexxa is intended for only about 50,000 Americans with gout who cannot be treated with other drugs.
In clinical trials, the drug worked for about 40 percent of patients, in some cases bringing marked improvement.
The small size of the studies made it impossible to determine whether an increase in heart problems among those taking Krystexxa was caused by the drug or was just chance. If the drug is approved, the advisory panel recommends further studies on Krystexxa safety and its use carefully restricted to those not helped by other therapies.
A handful of gout patients testified that the drug had dissolved unsightly and disabling lumps on their bodies, called tophi, and allowed them to walk or use their hands again. Savient paid for hotels and transportation for some patients to attend the meeting, which was in Silver Spring, Md.
Though Savient has not named a price for their drug, analysts estimate treatment to cost tens of thousands of dollars a year.
The FDA is expected to make a decision as to whether to grant marketing approval for Krystexxa by August 1, 2009.
For more information please see: http://investor.savient.com/ReleaseDetail.cfm?ReleaseID=390150