The FDA Arthritis Advisory Committee has recommended the approval of Pfizer's Tofacitinib for adult patients with moderately to severely active rheumatoid arthritis (RA).
The recommendation will be considered by the FDA in its review of the new drug application for tofacitinib.
Pfizer Specialty Care Medicines Development Group head and senior vice president Yvonne Greenstreet said, "The RA patient population needs additional treatment options, and Pfizer looks forward to working with the FDA on next steps as it completes its review of the tofacitinib application."
Once approved, tofacitinib would be the first new oral disease-modifying antirheumatic drug for RA in more than 10 years and the first RA treatment in a new class of medicines known as Janus kinase inhibitors, the company said.
Rheumatoid arthritis is a chronic inflammatory autoimmune disease that affects the hands and feet, although any joint lined by a synovial membrane may be affected.
