CHMP recommends approval of OBGEMSA™ (vibegron) for overactive bladder syndrome by Pierre Fabre Laboratories.

Pierre Fabre Laboratories received a positive CHMP opinion for OBGEMSA™ (vibegron) in overactive bladder syndrome (OAB). The European Medicines Agency's CHMP recommended approval of OBGEMSA™ for treating adult patients with OAB. Pierre Fabre Laboratories acquired an exclusive license from Urovant Sciences to register and commercialize vibegron in the European Economic Area in 2022. The decision will be reviewed by the European Commission, which may grant a marketing authorization for the drug.

April 26, 2024
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