FDA Expands Label for Krystexxa


The FDA approved a supplemental BLA for use of Krystexxa with methotrexate for the treatment of uncontrolled gout.

The FDA has approved the supplemental biologics license application (sBLA) expanding the labeling to include Krystexxa (pegloticase) injection co-administered with methotrexate. Developed by Horizon Therapeutics, Krystexxa is a biologic indicated to treat adult patients with uncontrolled chronic gout.

Elizabeth H.Z. Thompson, Ph.D.

Elizabeth H.Z. Thompson, Ph.D.

“Immunomodulatory therapies like methotrexate are often used with biologics to reduce the development of anti-drug antibodies and allow more patients to achieve a complete response. We anticipate this approval will encourage more physicians to recommend Krystexx with methotrexate to help their patients with uncontrolled gout receive the full benefits,” Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon, said in a press release.

The approval for use with methotrexate is based on the results from the MIRROR trial, which found that 71% of patients randomized to receive Krystexxa with methotrexate versus 39% of patients who received Krystexxa with placebo achieved the primary endpoint. The endpoint measured was the proportion of serum uric acid responders during month six. Additionally, 60% of patients who received the combination achieved a complete response during month 12 compared with 31% of patients who received the therapy with placebo.

Gout is a form of arthritis that causes severe attacks of pain, swelling and redness in joints. Pain and inflammation occur when too much uric acid crystallizes and deposits in the joints. Uncontrolled gout carries serious, long-term consequences in the joints. It is estimated that 3.9% of U.S. adults have gout.

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