European Commission grants Pierre Fabre approval for OBGEMSA in treating overactive bladder

FRANCE—The European Commission (EC) has authorized Pierre Fabre Laboratories to market OBGEMSA™ (vibegron), marking a significant milestone in managing overactive bladder syndrome (OAB) and providing a new treatment option for millions of European patients.

OAB is a common condition affecting over 70 million people in Europe and can significantly impact quality of life.

This approval comes after Pierre Fabre Laboratories acquired the exclusive license for vibegron from Urovant Sciences GmbH in 2022, allowing them to register and commercialize this innovative treatment in the European Economic Area.

The EC’s decision will apply across all EU member states, Iceland, Liechtenstein, and Norway, ensuring broad patient access.

 Pierre Fabre Laboratories’ granting of European marketing authorization for OBGEMSA follows the favorable opinion issued on April 25 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

This opinion was based on the comprehensive results of two pivotal, multicenter, double-blind, randomized phase 3 studies conducted in adults with overactive bladder symptoms.

Study RVT-901-3003 (EMPOWUR) evaluated the efficacy, tolerability, and safety of vibegron (at a dose of 75 mg per day) over 12 weeks compared to a placebo and with tolterodine as a positive control.

Its extension, study RVT-901-3004 (EMPOWUR Extension), double-blindly evaluated the long-term safety, tolerability, and efficacy of vibegron over 52 weeks, with tolterodine as an active comparator.

These studies demonstrated that vibegron, as a new selective agonist of beta-3 adrenergic receptors (AR), has a favorable benefit-risk profile in the symptomatic treatment of urgency, increased frequency of urination, and urge urinary incontinence (UUI) that can occur in patients with overactive bladder syndrome.

Commenting on this significant development, Eric Ducournau, CEO of Pierre Fabre Laboratories, expressed his delight and noted that this authorization will allow European patients to benefit from a new therapeutic option for overactive bladder syndrome.

 He emphasized that this decision further strengthens their expertise of over 40 years in urology.

Ducournau added that this decision confirms Pierre Fabre Laboratories’ commitment to offering patients innovative therapies that better manage chronic debilitating diseases.

This milestone is a testament to the company’s dedication to advancing healthcare and improving the quality of life for patients across Europe.

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