FDA panel recommends approval for Pfizer RA drug

FDA expected to decide whether or not to approve tofacitinib in August

NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Pfizer for treating rheumatoid arthritis.

Pfizer announced that the FDA Arthritis Advisory Committee voted 8-2 to recommend that the agency approve tofacitinib for moderately to severely active RA. The agency is not required to follow the recommendations of advisory committees, but usually does, and is expected to decide whether or not to approve the drug in August. Pfizer said that, if approved, tofacitinib would be the first new disease-modifying antirheumatic drug for RA in more than 10 years and the first RA treatment in a new class of medicines known as Janus kinase, or JAK inhibitors.

"We are pleased with the committee's positive evaluation of the tofacitinib data and its decision to recommend approval," Pfizer Specialty Care SVP and head of the medicines development group Yvonne Greenstreet said. "The RA patient population needs additional treatment options, and Pfizer looks forward to working with the FDA on next steps as it completes its review of the tofacitinib application."


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