The FDA is rejecting a new gout drug because of regulations.
May 9, 2012- Drug advisers for the FDA unanimously voted no for the Regeneron Pharmaceutical Inc’s experimental medication to prevent flare ups with Gout. The rebuff of the drug was due to studies that were only 16 weeks long.
An independent panel of experts voted 11-0 against the approval of the drug known as Arcalyst, an injectable drug. The vote was against the drug because the trials held were very short and hard to prove if the treatment was safe over the time the drug would be helping the patient.
Gout is a very painful condition. An attack of the condition takes plays when uric acid, the body waste product is deposited into soft tissue and joints that cause inflammation and at times so painful the sufferer cannot walk. The disease affects at least five and possibly six million people in the U.S.
Many patients that will plan to take the drug will most likely use it for over the 16 weeks. Panel recommendations are usually followed by the FDA. However, the FDA is not required to follow the recommendation and said it would announce its finding on July
The company’s drug known as rilonacept has already gained approval to treat a rare group of diseases.
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