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Pfizer Gets FDA Panel Backing For Tofacitinib To Treat Rheumatoid

Pfizer Inc. (PFE) Wednesday said that an FDA advisory panel has recommended approval for its investigational agent tofacitinib. Tofacitinib is developed for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

The Arthritis Advisory Committee to the FDA voted 8-2 to recommend approval. The FDA usually considers the panel's recommendation when deciding on Pfizer's New Drug Application for tofacitinib, though it is not bound to do so.

If tofacitinib gets FDA approval, it would be the first new oral disease-modifying antirheumatic drug for rheumatoid arthritis in more than 10 years.

Tofacitinib is a novel, oral Janus kinase inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis.

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.

Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet. The disease affects about 1.3 million Americans and 23.7 million people worldwide.

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