Pfizer: Tofacitinib Decision Delayed Until November

Pfizer (NYSE:PFE) announced this morning that the FDA delayed a decision on its rheumatoid arthritis treatment Tofacitinib by at least three months. The agency was expected to make a ruling on the New Drug Application (NDA) on August 21, which has subsequently been pushed into November. In July, Pfizer submitted additional information to the FDA regarding the development-stage treatment and warned investors that there may be a chance of delay. The FDA says that with so much new information, the agency will recognize the submission as an amendment to the original NDA and reschedule the PDUFA action date for later in the year. An outside panel of reviewers recommended to the FDA that Tofacitinb be approved as an option in RA treatment, with hesitancy based on some safety concerns.  (more…)