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FDA committee recommends against approval of Regeneron's Arcalyst as treatment for patients with gout

Tuesday, May 08 2012 | Comments
Evidence Grade 0 What's This?
The Food and Drug Administration's Arthritis Drugs Advisory Committee voted against recommending approval of Regeneron Pharmaceuticals Inc.'s Arcalyst (rilonacept) to prevent gout flares in patients who initiate uric acid-lowering therapy.

Earlier this month, FDA reviewers questioned the efficacy and safety of the drug in this indication, according to documents posted on the agency's website prior to the advisory committee meeting.

Arcalyst is already approved to treat a group of rare genetic autoinflammatory diseases. Other drugs are approved to treat gout flares, but none is approved specifically for patients who are starting therapy to lower their uric acid. The FDA reviewers said they were unsure whether Arcalyst is sufficiently effective for this patient population.

The reviewers also said that since Arcalyst is a biologic drug with the potential to increase the risk of infections and malignancy through immunosuppression, the proposed 16-week treatment duration should be considered from a safety standpoint. They called attention to data from the drug's gout development program that suggested there was an increased risk of malignancy events with Arcalyst as compared with placebo during a 16-week treatment period.

In its own briefing document, Regeneron acknowledged the apparent imbalance in malignancies but said further analysis of the data revealed that two patients were identified within the first month of therapy of having what were considered to be pre-existing cancers. During subsequent therapy, the firm noted, there was "no meaningful imbalance" between the Arcalyst and placebo treatment arms with respect to the percentages of patients with serious malignancies.

The company stated that there were "no safety findings in the types of adverse events that would be of concern," based on both the drug's mechanism of action and the patient population, and asserted that, overall, the safety data support the existence of a positive risk benefit for the proposed indication.

The FDA is scheduled to makes its decision regarding the supplemental Biologics License Application for Arcalyst by July 30.

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