Pfizer’s rheumatoid arthritis drug is approved by the FDA

Hannah Blake

pharmaphorum

Pfizer has received approval from the US FDA for its rheumatoid arthritis (RA) drug, Xeljanz, which is the first approved RA treatment in a new class of medicines known as Janus kinase inhibitors and the first new oral DMARD approved for RA in over 10 years.

The twice-daily treatment has been approved for adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. Xeljanz (tofacitinib citrate) has been approved to be used in two ways – either as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).

The FDA’s approval was based on seven clinical trials, which evaluated the safety and effectiveness of the treatment in adult patients with moderately to severely active RA. In each trial, patients treated with Xeljanz experienced improvement in clinical response and physical functioning compared to patients treated with placebo.

“Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate.”

Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

RA is an autoimmune disease which affects an estimated 1.5 million Americans, according to the Centers for Disease Control and Prevention.

As part of the approval requirements, the FDA has called for Pfizer to study the long-term effects of Xeljanz on heart disease, cancer and serious infections in a postmarketing study. This study will evaluate two doses of Xeljanz and will include a group of patients on another approved treatment to serve as a comparison.

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European-CME-Forum-15-16-November-2012

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Related news:

F.D.A. Clears a Pfizer Treatment for Rheumatoid Arthritis (New York Times)

FDA approves Pfizer drug to treat rheumatoid arthritis (Reuters)

Reference links:

Pfizer’s official press release

FDA’s official press release

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