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.