CHMP recommends approval of Xeljanz for active psoriatic arthritis.- Pfizer.

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xeljanz (tofacitinib), from Pfizer. The CHMP adopted a new indication as follows: Xeljanz in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

Comment: The FDA approval of Xeljanz for the treatment of adult patients with active PsA was based on data from the Phase III Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which consisted of two pivotal studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing long-term extension trial, OPAL Balance. The findings from OPAL Broaden and OPAL Beyond were published in October 2017 in the New England Journal of Medicine.