EU okays Pierre Fabre’s Obgemsa to treat overactive bladder symptoms

2024-07-01

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临床3期上市批准引进/卖出临床结果

The European Commission approved Pierre Fabre Laboratories’ Obgemsa (vibegron) for the symptomatic treatment of overactive bladder (OAB) syndrome in adults, more than three years after being cleared by the FDA.

The decision follows a positive stance adopted by the European Medicines Agency's (EMA) drug advisory body in April. Eric Ducournau, CEO of Pierre Fabre said the approval “will allow European patients to benefit from a new therapeutic option for OAB,” which is estimated to affect more than 70 million people in the region.

The approval was backed by findings from the Phase III EMPOWUR trial and a 52-week extension study, which showed that the 75-mg daily dose of Gemtesa significantly improved urgency, increased urination frequency, and urge urinary incontinence in patients with OAB compared with placebo.

In 2022, Pierre Fabre gained an exclusive license to commercialise vibegron in the EU from Sumitomo Pharma’s subsidiary Urovant Sciences, which markets it as Gemtesa in the US. The once-daily oral drug is also approved to treat symptoms of OAB in Japan and South Korea under the name Beova, where it is marketed by Kyorin Pharmaceutical and JEIL Pharmaceutical, respectively.

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