Pfizer Inc. (NYSE:PFE) said FDA Arthritis Advisory Committee recommended approval of tofacitinib for adult patients with moderately to severely active rheumatoid arthritis.
The Arthritis Advisory Committee to the U.S. Food and Drug Administration voted 8-2 to recommend approval of the investigational agent tofacitinib.
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 rheumatoid arthritis in more than 10 years and the first rheumatoid arthritis treatment in a new class of medicines known as Janus kinase (JAK) inhibitors.
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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.
Rheumatoid arthritis affects about 1.3 million Americans 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.
Tofacitinib has been evaluated in about 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.
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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.
PFE closed Wednesday's regular session up 1.13% at $22.45. The stock has been trading between $16.63 and $23.30 for the past 52 weeks.