Bristol Myers Squibb Gets CHMP Backing for Zeposia in Ulcerative Colitis

By Colin Kellaher

Bristol Myers Squibb Co. on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of its multiple-sclerosis drug Zeposia for the treatment of adults with moderately to severely active ulcerative colitis.

The New York biopharmaceutical company said the recommendation covers patients who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

The European Commission, which generally follows CHMP's advice, will now review the recommendation.

The U.S. Food and Drug Administration earlier this year approved Zeposia for adults with moderately to severely active ulcerative colitis, a chronic inflammatory bowel disease. U.S. and European regulators last year approved the drug for adults with relapsing forms of multiple sclerosis.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

10-15-21 0734ET