Research & Development
Pierre Fabre's OBGEMSA (vibegron)receives EC marketing authorisation for overactive bladder syndrome
1 July 2024 -

Pierre Fabre Laboratories, a France-based multinational pharmaceutical and cosmetics company, announced on Friday that it has received authorisation from The European Commission (EC) for marketing of OBGEMSA (vibegron) intended for the symptomatic treatment of overactive bladder syndrome in adults.

During 2022, the company acquired the exclusive license for vibegron from Urovant Sciences Gmbh for the registration and commercialisation of this treatment in the European Economic Area. This decision is applicable to all EU member states and Iceland, Liechtenstein, and Norway. The product is trademark owned by Urovant Sciences.

The decision is subsequent to the favourable opinion issued on 25 April by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). It is based on the results of two pivotal, multicentre, double-blind, randomised phase three studies in adults with overactive bladder symptoms.

Eric Ducournau, Pierre Fabre Laboratories CEO, said, 'We are delighted with this development, which will allow European patients to benefit from a new therapeutic option for overactive bladder syndrome and further strengthen our expertise of over 40 years in urology. This decision confirms Pierre Fabre Laboratories' commitment to offering patients innovative therapies that provide better management of chronic debilitating diseases.'