WASHINGTON (Reuters) – U.S. drug advisers unanimously voted against Regeneron Pharmaceuticals Inc’s experimental drug to prevent gout flares, based on studies that tested the drug for only 16 weeks.
A panel of outside experts to the U.S. Food and Drug Administration on Tuesday voted 11-0 against approving the injectable drug, rilonacept (Arcalyst), because its clinical trials were too short to prove the treatment was safe, or that it would help patients over time.
Gout affects about five million to six million Americans.
“A lot of the patients where we envision using this drug are going to take it for longer than 16 weeks. It’s hard for me to allow patients to be exposed (without longer safety data),” said panel member Dr. David Blumenthal, an assistant professor at Case Western Reserve University School of Medicine.
The FDA usually follows panel recommendations, although it is not required to, and will make a final decision on the drug by July 30.
Rilonacept is already approved to treat a group of rare genetic auto-inflammatory diseases. But the company is hoping to expand its use to prevent gout flares in people starting uric acid-lowering therapy.
To test its drug, Regeneron gave it to patients for 16 weeks, the length of time it said most people experience gout flare-ups. But panel members said in the most severe cases, people would need to take the drug for longer periods.