FDA advisory backs Pfizer's tofacitinib for RA

The US Food and Drug Administration’s Arthritis Advisory Committee yesterday voted eight to two to recommend approval of the investigational agent tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), causing the drug’s maker, global behemoth Pfizer (NYSE: PFE), shares – which had flagged earlier in the day – to rise about 1.2% to 22.47 in late trading.

The FDA advisors also voted seven to two that the drug was safe, and unanimously (10-0) that it was effective. The Committee’s recommendation will be considered by the FDA in its review of the New Drug Application for tofacitinib. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in August 2012. If approved by the agency, tofacitinib would be the first new oral disease-modifying antirheumatic drug (or DMARD) for RA in more than 10 years and the first RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors, s aid Pfizer.

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