FDA approves Pfizer's Xeljanz for psoriatic arthritis

Pfizer has revealed that the FDA has passed marketing approval for Xeljanz (tofacitinib) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).

Xeljanz was originally approved by the FDA in 2012. With this expanded indication, the drug has now been approved as a 5mg twice-daily dose and as an extended-release 11mg once-daily dose. The decision makes Xeljanz the first available FDA-approved Janus kinase (JAK) inhibitor for moderate to severe rheumatoid arthritis (RA) and active PsA.

The decision was based on the results of two Phase 3 trials which met their primary and secondary endpoints. In the first study, it was found that 50% of participants taking Xeljanz 5mg twice daily achieved an American College of Rheumatology 20 (ACR20) response compared to 33% in the placebo arm. The same percentage of patients recorded a response in the second trial on the same dose, compared to 24% of those on placebo.

Xeljanz generated $935 million for Pfizer in the first three quarters of this year, and this latest approval will bring them into the ring against Novartis’ Cosentyx and Eli Lilly’s Taltz, among others.

“Psoriatic arthritis is a complex and progressive disease with an unpredictable course,” commented Angela Hwang, Global President, Inflammation and Immunology at Pfizer. “The approval of Xeljanz is an important step forward for patients seeking new treatments and is a testament to Pfizer’s unwavering commitment to advancing patient care.”

Matt Fellows