FDA Arthritis Advisory Committee Recommends Approval of Tofacitinib for Adult Patients with Moderately to Severely Active Rheumatoid Arthritis
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that the Arthritis Advisory Committee to the U.S. Food and Drug Administration (FDA) voted 8-2 to recommend approval of the investigational agent tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The Committee’s recommendation will be considered by the FDA in its review of the New Drug Application (NDA) for tofacitinib. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) 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.
Source: press release, 5/09/12. http://www.pfizer.com/news/press_releases/pfizer_press_release.jsp?guid=...
Arthritis Advisory Committee Meeting Announcement
May 9, 2012 - 8:00 a.m. to 5:00 p.m.
On May 9, 2012, the committee will discuss new drug application (NDA) 203214, tofacitinib tablets, Pfizer Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Source: FDA.gov. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm295556.htm