Xeljanz was approved under the supplemental New Drug Application, according to a Dec. 14 news release. The approval was based on a phase 3 trial in 269 adults with active ankylosing spondylitis.
“This regulatory approval affirms the clinical value and versatility of Xeljanz, the first and only Janus kinase inhibitor approved for five indications in the United States for the treatment of patients with certain immuno-inflammatory conditions,” Mike Gladstone, Pfizer’s global president of inflammation and immunology, said in the release.
