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BMS’ Zeposia gains FDA approval in ulcerative colitis

Treatment was initially approved in 2020 for multiple sclerosis

Bristol Myers Squibb’s S1P receptor modulator Zeposia has received US Food and Drug Administration (FDA) approval for the treatment of moderately to severely active ulcerative colitis (UC).

The FDA has approved Zeposia (ozanimod) for the treatment of the chronic inflammatory bowel disease based on data from the phase 3 True North study.

The trial met its primary endpoint of clinical remission during induction at week 10, as well as secondary endpoints including clinical response, endoscopic improvement and endoscopic-histologic mucosal improvement for Zeposia versus placebo.

During maintenance at week 52, Zeposia also improved clinical remission and met the same key secondary endpoints as listed above.

In addition, decreases in rectal bleeding and stool frequency subscores were observed as early as week 2 in patients treated with BMS’ therapy.

“Despite the availability of approved therapies, there is still unmet need and an opportunity to deliver additional treatment options to help patients better manage their disease,” said Adam Lenkowsky, general manager and head, US, cardiovascular, immunology and oncology, BMS.

“We’re thrilled that our pursuit of transformative science in immunology may benefit patients in their ulcerative colitis treatment by introducing a new option that has a different mechanism of action than available therapies. Zeposia combines disease control through lasting remission and demonstrated safety in a once-daily pill,” he added.

Zeposia was initially approved by the FDA for the treatment of relapsing forms of multiple sclerosis (RMS) in March 2020, while the European Commission also authorised the drug for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease in May 2020.

The European Medicines Agency (EMA) has already validated BMS’ marketing authorisation application (MAA) for Zeposia in UC, with a regulatory decision expected in the second half of 2021.

Zeposia is designed to bind to S1P receptors 1 and 5, reducing the capacity of lymphocytes to migrate from lymphoid tissue and decreasing the number of circulating lymphocytes in the blood.

Although the mechanism by which Zeposia induces a therapeutic effect in UC is unknown, BMS said it may involve the reduction of lymphocyte migration into the intestines.

Article by
Lucy Parsons

1st June 2021

From: Regulatory

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