Bristol Myers: ulcerative colitis drug approved

(CercleFinance.com) - Bristol Myers Squibb has announced that the European Medicines Agency has validated its marketing authorisation application for Zeposia (ozanimod) in the treatment of adults with moderately to severely active ulcerative colitis.


The pharmaceutical company explained that this validation enables the start of the centralised review process with a view to the product's potential approval in this indication in the European Union.

The dossier is based on the pivotal phase III True North study, which showed "significant" results in terms of clinical remission compared to placebo, with a safety profile in line with that known in previously approved indications.


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