FDA Recommends Approval of Tofacitinib

Oral disease modifying antirheumatic drug

/ Author:  / Reviewed by: Natasha Levin

Pfizer Inc. announced that the Arthritis Advisory Committee to the U.S. Food and Drug Administration (FDA) voted 8-2 to recommend approval of the investigational agent tofacitinib" data-scaytid="1">tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

The Committee’s recommendation will be considered by the FDA in its review of the New Drug Application (NDA) for tofacitinib. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in August 2012.

If approved by the FDA, tofacitinib 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.”

Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. RA affects approximately 1.3 million Americans1 and 23.7 million people worldwide.

Although multiple treatments are available, many patients do not adequately respond, and there remains a need for additional options.

About Tofacitinib

Tofacitinib is a novel, oral JAK inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for RA. Unlike more recent therapies for RA, which are directed at extracellular targets such as pro-inflammatory cytokines, tofacitinib takes a novel approach targeting the intracellular pathways that operate as hubs in the inflammatory cytokine network.

Tofacitinib has been evaluated in approximately 4,800 patients yielding 7,000 patient-years of exposure in a comprehensive, global clinical development program that included five pivotal Phase 3 trials and two ongoing long-term extension studies in 45 countries.

Tofacitinib is currently under review for the treatment of moderately to severely active RA by several regulatory agencies around the world, including the United States, Europe and Japan.

Reviewed by: 
Review Date: 
May 10, 2012
Last Updated:
August 13, 2012