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Regeneron Drug Arcalyst To Be Reviewed For Gout Treatment

Posted by Claire Shefchik on November 23, 2011 1:01 PM
Regeneron reported positive data from two trials of cholesterol drug REGN727 on Thursday.

Regeneron Pharmaceuticals Inc. announced Tuesday that the Food and Drug Administration has agreed to review its drug Arcalyst as a gout treatment.

The review will be complete by July 30, according to the company.

Arcalyst is currently approved to treat CAPS, a collection of inherited, auto-inflammatory conditions, The Associated Press reported. The company reported $5.5 million in third-quarter sales of the drug.

"We believe that Arcalyst has the potential to become an important new therapy for patients with gout who are initiating uric acid-lowering therapies," Dr. George D. Yancopoulos, president of Regeneron Research Laboratories, said in a news release.  "Gout is a serious and sometimes debilitating disease, characterized by elevated levels of uric acid in the blood, which requires treatment with uric acid-lowering therapy to avoid gout flares and its long-term complications. The availability of a treatment that can help avoid gout flares during the initial months of uric acid-lowering therapy has the potential to help patients with this disease."

Also Friday the FDA approved the company's drug Eylea to treat "wet" age-related macular degeneration, which causes blindness in elderly patients.

"The approval of Eylea offers a much needed new treatment option for patients with wet AMD," said Dr. Jeffrey Heier, a clinical ophthalmologist and retinal specialist at Ophthalmic Consultants in Boston, assistant professor of ophthalmology at Tufts School of Medicine, and trial committee chair. "Eylea offers the potential of achieving the efficacy we've come to expect from current anti-VEGF agents, but with less frequent injections and monitoring. This may reduce the need for costly and time-consuming monthly office visits for patients and their caregivers." The AP reported shares of Regeneron rose 10.4 percent Monday. They gained $1.07, or 2 percent, rising to $56.07 in Tuesday afternoon trading. To date, the stock is up 70 percent.  
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