FDA puts back action date on Pfizer's tofacitinib by three months

Pfizer (NYSE: PFE), the world’s largest drugmaker by sales, yesterday revealed that the US Food and Drug Administration has extended the action date by three months for the New Drug Application for tofacitinib, an investigational oral treatment for adults with moderately to severely active rheumatoid arthritis. Pfizer’s shares dipped less that 1% to $23.69 on the news.

The news was largely expected as, along with its recent financial results presentation, Pfizer said that the FDA had requested additional analysis of the existing data in the tofacitinib NDA, which the company said it planned to provide in early August and, given this timing, it anticipated that FDA may require additional time beyond the August 21 Prescription Drug User Fee Act (PDUFA) date to review the data (The Pharma Letter August 1). Pfizer says that the FDA determined that additional data analyses recently submitted constitute a major amendment to the application and will require additional time to review, with the PDUFA date now set for November 21.