Pfizer: possible regulatory delay for tofacitinib

Pfizer Inc. (NYSE:PFE) said FDA requested additional analysis of data in an NDA for tofacitinib, which the pharma said could cause the agency to extend its review of the rheumatoid arthritis product past its Aug. 21 PDUFA date. According to Pfizer, FDA made the request after a May meeting of the Arthritis Advisory Committee, which voted 8-2 in favor of recommending approval of tofacitinib. The panel also voted 8-2 that the data did not provide substantial evidence of the efficacy for radiographic outcomes. Pfizer plans to submit the additional analysis in early August. Specific details about the request were not disclosed (see BioCentury, May 14).

Pfizer also reported top-line data from the Phase III ORAL Start trial showing that tofacitinib met the co-primary endpoints of improving modified Total Sharp Score (mTSS) on radiographic scans and ACR70 response rate from baseline to six months vs. methotrexate. The trial enrolled 958 methotrexate-naive patients with moderate to severe active RA. The ORAL program of tofacitinib for RA comprises six trials. Data from the first five trials were submitted as part of the NDA. Pfizer said ORAL Start was not required by FDA or EMA for registration, but the pharma is exploring the "most appropriate method and timing" to submit the ORAL Start data to FDA. ...