FDA Accepts New Drug Application for Tofacitinib

The US Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for tofacitinib from Pfizer Inc., the company announced last week.

Tofacitinib is an oral JAK inhibitor currently being investigated for the treatment of adults with moderate to severe rheumatoid arthritis (RA). An estimated 1.3 million Americans and a total 1% of the world’s population are believed to suffer from RA, a chronic inflammatory autoimmune disease.

The European Medicines Agency agreed to review an application for tofacitinib as an RA treatment in November, and Pfizer has submitted an application for tofacitinib to regulatory authorities in Japan as well.

"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 for specialty care and oncology at Pfizer, in a press release.

"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,” Germano continued.

The FDA has announced a predicted Prescription Drug User Fee Act (PDUFA) action date for the NDA of August 2012.