Committee Votes in Favor of RA Drug Despite Lymphoma Concerns


Major pharmaceutical company Pfizer is announcing today that the US Food and Drug Administration's Arthritis Advisory Committee has voted 8-2 to recommend approval of the investigational agent tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

The FDA will consider the Committee's recommendation when it reviews Pfizer's New Drug Application (NDA) for tofacitinib. The FDA isn't beholden to the Committee's vote, but it generally takes its recommendation.

If the Agency approves tofacitinib, it would be the first new oral disease-modifying antirheumatic drug (or DMARD) for RA in more than 10 years and the first RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors.

“We are pleased with the Committee's positive evaluation of the tofacitinib data and its decision to recommend approval,” said Dr. Yvonne Greenstreet, senior vice president and the head of Medicines Development Group for Pfizer Specialty Care. “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.”

This is a somewhat surprising recommendation considering the concerns that had been expressed prior to the meeting, concerns that included what some considered an unacceptably high incidence of lymphoma among participants in clinical trials for the drug.

Source: Therapeutics Daily

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