FDA accepts Pfizer's tofacitinib NDA for review

Dec 21 2011

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tofacitinib (development code CP-690,550), an investigational novel, oral JAK inhibitor being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in August 2012 for the NDA. Pfizer has also submitted an application for this indication for tofacitinib to regulatory authorities in Japan.

As disclosed in November, an application for tofacitinib for the treatment of adult patients with moderate-to-severe active RA is being reviewed by the European Medicines Agency.

"Pfizer is pleased to have achieved this regulatory milestone, which reflects our commitment to advancing treatments for inflammatory conditions, and constitutes a significant step toward bringing tofacitinib to RA patients who are in need of additional therapeutic options," said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer Inc. "We are proud of the comprehensive Phase 3 clinical program that we have completed and believe that, if approved by the FDA, tofacitinib has the potential to improve the lives of people with RA."