The U.S. Food and Drug Administration has extended the date when they will act on the New Drug Application for tofacitinib by three months. The decision regarding tofacitinib was expected August 21, 2012. Tofacitinib is an oral treatment for adults with moderately to severely active rheumatoid arthritis. The drug has been highly anticipated. If the FDA approves tofacitinib, it will be the first rheumatoid arthritis treatment in a new class of drugs known as Janus kinase (JAK) inhibitors.
The decision was postponed when the FDA determined that additional data analyses recently submitted by Pfizer required more time to review. The decision is now expected by November 21, 2012.
- Tofacitinib Recommended for FDA Approval to Treat Rheumatoid Arthritis (5/9/12)
- Data on Tofacitinib Offers Mixed Results for Safety and Effectiveness (9/23/2011)
- Tofacitinib for Rheumatoid Arthritis - Phase 3 Results Draw Attention (4/22/2011)
- Severe Rheumatoid Arthritis - What You Need to Know
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