FDA to review Pfizer’s experimental arthritis drug

The US Food and Drug Administration (FDA) has accepted a new drug application for tofacitinib, an experimental drug to treat moderately to severely active rheumatoid arthritis, for review.

The regulator set an action date for August 2012 to review Pfizer’s investigational novel, oral JAK inhibitor.

Pfizer has also submitted an application for this indication for tofacitinib to regulatory authorities in Japan and applied for approval from the European Medicines Agency.

Pfizer president and general manager for specialty care and oncology Geno Germano said, "We are proud of the comprehensive Phase III clinical programme that we have completed and believe that, if approved by the FDA, tofacitinib has the potential to improve the lives of people with for review."

Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet affecting approximately 1.3 million Americans and 1% of the worldwide population.