U.S. FDA approves Bristol Myers Squibb’s bowel disease treatment

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Bristol Myers Squibb

U.S. FDA approves Bristol Myers’ bowel disease treatment

(Reuters) – Bristol Myers Squibb (BMY.N) said on Thursday the U.S. Food and Drug Administration approved its oral drug Zeposia to treat adults with ulcerative colitis, a chronic inflammatory bowel disease.

Bristol Myers gained the drug, approved last year for treating multiple sclerosis patients, in 2019 through its $74 billion buyout of Celgene.

A sign stands outside a Bristol Myers Squibb facility in Cambridge, Massachusetts, U.S., May 20, 2021. REUTERS/Brian Snyder

Zeposia last year June met the main goals of a late-stage study, showing patients who took it achieved clinical remission of ulcerative colitis when compared to placebo. (https://reut.rs/2SA6RFe)

Cowen analyst Steve Scala, in a note on May 23, estimated Zeposia sales of $150 million in 2021, $400 million in 2022 and $1 billion in 2025.

Zeposia will compete with Takeda Pharmaceutical Co’s (4502.T) drug Entyvio, which was approved in 2014 by the FDA for ulcerative colitis.

The European Medicines Agency is currently reviewing the marketing application for Zeposia to treat ulcerative colitis. A decision from the agency is expected in the second half of 2021, Bristol Myers said.

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