Updates on Pfizer’s Xeljanz
On August 1, Pfizer (PFE) announced that the European Commission approved Xeljanz (tofacitinib citrate) for the treatment of ulcerative colitis in patients who are intolerant to or had an inadequate response to conventional therapy or a biologic agent.
The above chart shows key highlights for Pfizer’s Xeljanz.
Xeljanz (tofacitinib citrate) is the only janus kinase inhibitor approved by the US Food and Drug Administration for the following 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 mentioned above are pending globally.
EC and Xeljanz
The approved treatment includes Xeljanz 10-mg twice daily for at least eight weeks with a further dosage of Xeljanz 5-mg or 10-mg twice daily. In June 2018, Xeljanz was approved in combination with methotrexate for the treatment of active psoriatic arthritis in patients who were intolerant to disease-modifying anti-rheumatic drugs. Also, Xeljanz was approved in combination with methotrexate for the treatment of active rheumatoid arthritis in patients who were intolerant to disease-modifying antirheumatic drugs.
The approval was based on phase three OCTAVE studies including OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain studies, and also an ongoing long-term extension study, OCTAVE Open.