Pfizer submits regulatory application for rheumatoid arthritis drug to FDA
NEW YORK — Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.
The company said the FDA accepted a new drug application for tofacitinib for review. The agency also has provided an anticipated Prescription Drug User Fee Act action date of August 2012. Tofacitinib, which is a novel, oral JAK inhibitor, currently is under review 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 of specialty care and oncology at Pfizer. “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.”