FDA extends action date for Pfizer’s tofacitinib NDA review

Aug 22 2012

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the New Drug Application (NDA) for tofacitinib, an investigational oral treatment for adults with moderately to severely active rheumatoid arthritis (RA). If approved, tofacitinib would be the first RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors and the first new oral disease-modifying antirheumatic drug (or DMARD) for RA in more than 10 years.    

The FDA determined that additional data analyses recently submitted by Pfizer constitute a major amendment to the application and will require additional time to review. The FDA has not asked that Pfizer complete any new studies. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) date of November 21, 2012.

"RA patients are in need of additional treatment options to help fight this serious chronic inflammatory autoimmune disease," said Dr. Yvonne Greenstreet, senior vice president and head of the Medicines Development Group for Pfizer Specialty Care. "We believe that the results from the comprehensive multi-study clinical development program for tofacitinib have demonstrated a favorable benefit-risk profile, and we remain committed to working expeditiously with the FDA to make tofacitinib available to patients."

Pfizer continues to progress the applications for tofacitinib for the treatment of moderately to severely active RA in markets outside the United States, including Europe and Japan.

Tofacitinib has one of the largest clinical databases of any RA drug ever submitted to the FDA for review. The medication has been evaluated in a comprehensive, multi-study, global clinical development program that included approximately 5,000 patients who represented a broad cross-section of the RA patient population in 44 countries.