FDA Advisory Committee recommends tofacitinib (Pfizer) for Rheumatoid Arthritis

The Arthritis Advisory Committee to the FDA voted 8-2 to recommend approval of the investigational agent tofacitinib from Pfizer for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis (RA). The FDA has provided an anticipated Prescription Drug User Fee Act action date in August 2012. If approved by the FDA, 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.