FDAnews Drug Daily Bulletin

Pfizer RA Drug Could Be Delayed Past August by FDA Data Request

Aug. 9, 2012
Pfizer’s rheumatoid arthritis (RA) candidate tofacitinib could see its review date pushed back thanks to an FDA request for an additional analysis. The company plans to provide the analysis of existing data in early August, ahead of the drug’s originally scheduled Aug. 21 action goal date, CEO Ian Read said Tuesday during the company’s second-quarter earnings call. Any delay could be a small positive for Abbott’s Humira (adalimumab), Wells Fargo analyst Larry Biegelsen noted. Every $100 million in tofacitinib sales would result in about $25 million in lost Humira sales, Biegelsen estimates.
Washington Drug Letter