Pfizer Inc. (PFE: Quote) said it Phase 3 study of tofacitinib in moderate-to-severe active rheumatoid arthritis patients met primary endpoints in 5 mg and 10 mg twice daily doses. The randomized ongoing two year study - Oral Rheumatoid Arthritis study or ORAL Start - recorded statistically significant changes shown in inhibiting structural damage and in reducing signs and symptoms of Rheumatoid Arthritis. The changes were measured using modified Total Sharp Score.
Tofacitinib is an oral Janus kinase or JAK inhibitor. Tofacitinib was found to be superior to monotherapy or MTX. The primary objectives of ORAL Start are to compare preservation of joint structure, treatment of signs and symptoms and safety and tolerability with tofacitinib 5 or 10 mg BID versus MTX.
Pfizer separately announced that the U.S. Food and Drug Administration has requested additional analysis of the existing data in the tofacitinib New Drug Application. The company is planning to provide FDA with this information in early August and, given this timing, it anticipates that FDA may require additional time beyond the August 21 Prescription Drug User Fee Act date to review the information.
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by RTT Staff Writer
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