FDA Panel Recommends Approval of Tofacitinib for Psoriatic Arthritis
Pfizer announced that the Food and Drug Administration (FDA)'s Arthritis and Advisory Committee has voted in favor (10–1) to recommend approval of tofacitinib (Xeljanz, Xeljanz XR) for the treatment of adults with active psoriatic arthritis (PsA).
The supplemental New Drug Applications (sNDAs) contained data from Phase 3 trials involving patients with psoriatic arthritis, including safety analyses from the larger tofacitinib clinical development program. The proposed indication was for Xeljanz 5mg twice daily and Xeljanz XR 11mg once daily. If approved, tofacitinib would be the first Janus kinase (JAK) inhibitor to treat psoriatic arthritis.
Xeljanz and Xeljanz XR are currently approved to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate was not effective; it may be used as a single agent or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).
Xeljanz is available as 5mg strength tablets in 28-, 60-, and 180-count bottles. Xeljanz XR is available as 11mg strength tablets in 14- and 30-count bottles.
While not bound by the Advisory Committee's recommendation, the FDA takes its guidance into consideration. The FDA's decision on tofacitinib approval for psoriatic arthritis is expected in December 2017.
For more information call (800) 438-1985 or visit Xeljanz.com.