FDA Urged to Approve New Gout Drug, Despite Risks

Just days after Food and Drug Administration officials said a proposed new drug was effective for treating the severe form of arthritis called gout but also carried the potential for deadly side effects, an advisory panel of medical experts has recommended the FDA approve the new drug.

The experimental infused drug, called Krystexxa and made by Savient Pharmaceuticals Inc., is intended for treating patients with the severe joint disorder that causes swollen joints and chronic pain. Last week, an FDA report raised serious concerns about the safety of the drug, which has been associated with cardiovascular injuries and other injuries.

In clinical studies, nearly one in four patients taking Krystexxa, which is known generically as pegloticase, experienced a serious or deadly side effect compared to just 12 percent of patients given placebo pills. Those results prompted some in the FDA to raise concerns about the safety and efficacy of the proposed new drug.

However, the panel of outside experts overwhelming supported approval of Krystexxa by a vote of 14-1. The panel said results of pre-marketing tests were encouraging, even when increased risks of heart problems, allergic reactions, and sudden death were factored in to the evaluation.

While the FDA is not required to follow the recommendations of its advisory panels, most of the time, the agency falls in line with its panels and either approves or denies a new drug based on the recommendations. It is not yet clear how long the FDA will take to issue a decision on Krystexxa.

Savient Pharmaceuticals Inc. is a small, boutique biotech firm based in East Brunswick, N.J. that has just one other product currently on the United States market. FDA approval of Krystexxa would be a boon to the company.

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