Pfizer’s Xeljanz becomes first JAK inhibitor approved in US for active ulcerative colitis

pharmafile | May 31, 2018 | News story | Sales and Marketing FDA, Pfizer, US, Xeljanz, pharma, ulcerative colitis 

Pfizer has revealed that its Janus kinase (JAK) inhibitor Xeljanz (tofacitinib) has received FDA approval for the treatment of adult patients with moderately to severely active ulcerative colitis, making it the first and only therapy of its kind available for the condition in the US.

The authorisation was based on data from three Phase 3 trials, as well as an ongoing open label long-term extension study. All three trials met their primary endpoint, with Xeljanz helping more patients achieve remission after eight weeks in induction studies and 52 weeks in the maintenance study compared to placebo, as defined as a Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and a rectal bleeding subscore of 0.

A number of risks were noted in the studies, including gastrointestinal perforation, serious infections such as herpes zoster, and malignancies including non-melanoma skin cancer and lymphoproliferative disorders.

Xeljanz is already approved in the US for the treatment of moderately to severely active rheumatoid arthritis (RA) and active psoriatic arthritis (PsA), and was recently approved for moderate to severe UC in Japan and Russia.

“Ulcerative colitis is a chronic inflammatory bowel disease that can significantly impact the lives of patients and has limited therapeutic options available,” remarked Michael Goettler, Global President, Inflammation and Immunology at Pfizer. “With the FDA approval of Xeljanz, adults living with moderately to severely active UC now have an oral option that may help achieve and maintain steroid-free remission.”

Michael Osso, President & CEO of the Crohn’s & Colitis Foundation, also added: “What works for one ulcerative colitis patient may not work for another and some struggle with ongoing symptoms. That is why it is so critical that our patients have different treatment options available to them. We are thrilled to have this new treatment option available to ulcerative colitis patients. Every new treatment provides new hope to our community.”

Matt Fellows

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