EU approves Pfizer's fifth indication for oral JAK inhibitor tofacitinib

Pfizer recently announced that the European Commission (EC) has approved a new indication for the anti-inflammatory drug Xeljanz (tofacitinib, tofacitinib): for the treatment of active ankylosing spondylitis (AS) that does not respond to conventional treatments.

It is worth mentioning that Xeljanz is the first and only oral JAK inhibitor approved for 5 indications in the EU, and is the most among all JAK inhibitors.

The AS indication approval is based on the positive results of a phase 3 clinical study (A3921120)

A3921120 is a multi-center, double-blind, placebo-controlled phase 3 study, conducted in 270 adult patients with active AS, these patients meet the modified AS New York criteria (MNY), and two or more non-steroidal Insufficient response or intolerance to anti-inflammatory drugs (NSAID) treatment

The results showed that the study reached the primary endpoint: at the 16th week of treatment, compared with the placebo group, the proportion of patients who achieved an ASAS20 response in the Xeljanz treatment group increased significantly (56.

Ankylosing spondylitis (AS) is a chronic inflammatory disease that affects both men and women in early adulthood

The active pharmaceutical ingredient of Xeljanz is tofacitinib, which is an oral JAK inhibitor that can selectively inhibit JAK kinase and block the JAK/STAT pathway, which is a signal transduction stimulated by cytokines Pathway, involved in many important biological processes such as cell proliferation, differentiation, apoptosis and immune regulation

In the Chinese market, Xeljanz was approved for marketing in March 2017 for the treatment of moderate to severely active RA adult patients with insufficient or intolerable MTX treatment