Drug/Device PipelinePerspective

FDA Approves Xeljanz Extended Release Tablets for UC

The FDA on Thursday approved Xeljanz extended release 11 mg and 22 mg tablets for the once daily treatment of adults with moderately to severely active ulcerative colitis, following an inadequate response or intolerance to previous TNF blocker therapy, according to a press release from the manufacturer.

“Ulcerative colitis is a chronic inflammatory disease of the colon that can significantly affect a patient’s quality of life and be emotionally burdensome due to symptoms, flares and complications,” Michael Corbo, chief development officer of Inflammation & Immunology at Pfizer Global Product Development, said in the release. “We are pleased to now offer patients with moderately to severely active ulcerative colitis and their health care providers a convenient once daily dosing option with Xeljanz.”

The manufacturer does not recommend the use of Xeljanz/Xeljanz XR (tofacitinib, Pfizer) in combination with other biologic therapies for UC or with other immunosuppressants such as azathioprine and cyclosporine.

From the first 8 to 16 weeks of induction therapy, tofacitinib 10 mg twice daily or tofacitinib extended release 22 mg once daily may be prescribed.

Following induction therapy, tofacitinib 5 mg twice daily or tofacitinib extended release 11 mg once daily may be prescribed as a maintenance therapy. Additionally, tofacitinib 10 mg twice daily or tofacitinib extended release 22 mg once daily may be considered for treatment but should be limited to the shortest duration with careful consideration of benefits and risks to each patient, according to the release.

Source:

Pfizer.com

The FDA on Thursday approved Xeljanz extended release 11 mg and 22 mg tablets for the once daily treatment of adults with moderately to severely active ulcerative colitis, following an inadequate response or intolerance to previous TNF blocker therapy, according to a press release from the manufacturer.

“Ulcerative colitis is a chronic inflammatory disease of the colon that can significantly affect a patient’s quality of life and be emotionally burdensome due to symptoms, flares and complications,” Michael Corbo, chief development officer of Inflammation & Immunology at Pfizer Global Product Development, said in the release. “We are pleased to now offer patients with moderately to severely active ulcerative colitis and their health care providers a convenient once daily dosing option with Xeljanz.”

The manufacturer does not recommend the use of Xeljanz/Xeljanz XR (tofacitinib, Pfizer) in combination with other biologic therapies for UC or with other immunosuppressants such as azathioprine and cyclosporine.

From the first 8 to 16 weeks of induction therapy, tofacitinib 10 mg twice daily or tofacitinib extended release 22 mg once daily may be prescribed.

Following induction therapy, tofacitinib 5 mg twice daily or tofacitinib extended release 11 mg once daily may be prescribed as a maintenance therapy. Additionally, tofacitinib 10 mg twice daily or tofacitinib extended release 22 mg once daily may be considered for treatment but should be limited to the shortest duration with careful consideration of benefits and risks to each patient, according to the release.

Source:

Pfizer.com

    Perspective
    David P. Hudesman

    David P. Hudesman

    When we talk about patients and think about what drug is right for the patient, we want to ensure it is efficacious. The first priority is you want to ensure it is going to work. Then you want to think about the safety profile, followed by other factors such as rapidity of action and mode of administration. You also need to consider whether your patient going to take medication. A lot of patients, though not all, prefer oral agents. And, in this case with the Xeljanz approval, we think a patient would much rather take an agent once a day than twice a day. We currently see that with other therapies including mesalamine-based therapies. But, could that improve adherence? We need more data on that. But from a physician perspective, we think patients might be more compliant with their medications.

    • David P. Hudesman, MD
    • Co-Director,
      Inflammatory Bowel Disease Center at NYU Langone Health

    Disclosures: Hudesman reports serving as a consultant for, and receiving research funding from, Pfizer.

    Perspective
    Miguel Regueiro

    Miguel Regueiro

    Xeljanz is a great new option as a once daily oral pill therapy for our patients with ulcerative colitis. Tofacitinib 22 mg extended release would be the equivalent of giving 10 mg twice daily; and although twice a day does not sound like a big deal, it still is something that people – in terms of adherence and compliance – would rather take once a day. Further, the efficacy is likely going to be the same, so using that over a twice daily therapy may be what we are going to do once it’s in the pharmacies.

    • Miguel Regueiro, MD
    • Chairman, Department of Gastroenterology, Hepatology and Nutrition
      Cleveland Clinic

    Disclosures: Regueiro reports consulting for AbbVie, Janssen, Pfizer, Takeda, Genentech, Gilead, Salix, Prometheus, Celgene.

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