Clinical Bristol Myers Squibb's multiple sclerosis drug Zeposia gets FDA...

Bristol Myers Squibb’s multiple sclerosis drug Zeposia gets FDA approval for ulcerative colitis

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The drug Ozanimod (zeposia) has been approved by United States FDA (Food and Drug Administration) for individuals having mild to Severe Ulcerative Colitis.

Ozanimod is the very first S1P (Sphingosine-1-Phosphate) receptor modulator licensed to be used in Ulcerative Colitis. It is taken in a dose of 0.92 mg PO (by mouth) OD (once a day). This drug was approved by FDA for individuals with recurrent multiple sclerosis, in March 2020.

The FDA approved Ozanimod for ulcerative colitis based on the results obtained from a phase-lll placebo-controlled clinical trial known as True North, that assessed the medication as an initial treatment for 645 individuals (approximately 60% males with 45 years of age) over 10 weeks for mild to moderate ulcerative colitis, followed by the maintenance treatment for more than 42 weeks.

All of the subjects in the trial had previously failed to respond to corticosteroids, oral aminosalicylates, biologics, or immunomodulators, and 30% of the patients had previously failed to respond to the treatment or were allergic to TNF (Tumor Necrotic Factor) inhibitors. Patients were given oral aminosalicylates or/and corticosteroids before and during the induction therapy.

The trial accomplished its primary goal during the induction therapy at 10th week, substantially more individuals using Ozanimod than those taking placebo attained clinical remission (18% vs 6%).

Ozanimod also outperformed placebo in secondary goals such as clinical response (48% v/s 26%), endoscopic-histologic mucosal improvements (13% v/s 4%), and endoscopic improvements (27% v/s 12%).

“In True North, Zeposia demonstrated efficacy for endpoints such as clinical remission, endoscopic and histological mucosal improvement, and safety. All are very relevant considerations for patients with ulcerative colitis,” Michael Chiorean, Co-Director, MD, IBD Center, Swedish Medical Center, Seattle, Washington, said in a company news release.

“Ulcerative colitis can be debilitating and unpredictable for the people living with this chronic inflammatory bowel disease,” Michael Osso, president and Chief Executive Officer of the Crohn’s and Colitis Foundation, said in the release.

“The approval of this new oral treatment is welcome news for our community and provides hope to many patients who are looking for new options to achieve symptom relief and remission,” he added.

Patients who were taking Ozanimod experienced common side effects such as LFTs (liver function tests) abnormalities, headaches, and Upper respiratory tract infections.

Ozanimod is not allowed to be used in patients who have a past 6 months history of heart diseases such as unstable angina, decompensated heart failure, myocardial infarction, transient ischemic attack, and many other atrioventricular blockages. It is also prevented to be used in patients with severe sleep apnea which is left untreated, and in patients taking MAOs (Monoamine oxidase inhibitors).

Ozanimod can make a patient more susceptible to the infection. All the patients must have a CBC (Complete Blood Count) before starting the treatment. Patients must be examined during the therapy and for 3 months after the completion of the treatment. The treatment should not be started in case of an existing infection.

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