Updates on Pfizer’s Xeljanz
Pfizer (PFE) announced in a press release yesterday that the European Commission has approved its marketing authorization application for Xeljanz in combination with methotrexate for active psoriatic arthritis.
The above chart shows key highlights for Xeljanz.
Xeljanz (tofacitinib citrate) is the only Janus kinase inhibitor approved by the FDA for these three indications:
- rheumatoid arthritis
- active psoriatic arthritis
- moderate-to-severe active ulcerative colitis
Xeljanz is approved in over 80 countries for rheumatoid arthritis, and additional regulatory applications for all three indications are pending globally.
EC and Xeljanz
Yesterday, Pfizer announced that Xeljanz 5 mg received marketing authorization for the European Union for use in combination with methotrexate for active psoriatic arthritis in patients who have been intolerant of disease-modifying anti-rheumatic drugs. The approval was based on data from the Oral Psoriatic Arthritis Trials (or OPAL), including data from OPAL Beyond, OPAL Broaden, and the ongoing OPAL Balance study.
Oral Psoriatic Arthritis Trials
The approval for Xeljanz 5 mg twice-daily in combination with methotrexate was based on data from two studies, OPAL Beyond and OPAL Broaden. The results of OPAL Beyond and OPAL Broaden were released by Pfizer in November 2016 and presented at the ACR/ARHP Annual Meeting in Washington, DC.
OPAL Balance is an ongoing long-term extension study evaluating the safety, efficacy, and tolerability of tofacitinib in patients with active psoriatic arthritis.