Pierre Fabre Laboratories has received the European Commission (EC) marketing authorisation for Obgemsa (vibegron) to treat a type of overactive bladder (OAB) syndrome in adults.
Obgemsa was first discovered by scientists at US pharmaceutical firm Merck & Co. and was later developed by Kyorin Pharmaceutical, Kissei Pharmaceutical, and Urovant Sciences.
In 2022, Pierre Fabre acquired the exclusive license for Obgemsa in the European Economic Area, from clinical-stage biopharmaceutical company Urovant Sciences.
Under the EC authorisation, the company is allowed to market the drug in all EU member states, along with Iceland, Liechtenstein, and Norway.
Pierre Fabre Laboratories CEO Eric Ducournau 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.”
The EC authorisation follows the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) positive opinion granted on 25 April 2024.
The recommendation is based on the results of two pivotal, multicentre, double-blind, randomised Phase 3 studies in adults with overactive bladder symptoms.
The Study RVT-901-3003 (EMPOWUR) evaluated the efficacy, tolerability, and safety of vibegron 75mg per day, compared to placebo and with tolterodine as a positive control.
Its extension, study RVT-901-3004 (EMPOWUR Extension) is a double-blind study that evaluated the long-term safety, tolerability, and efficacy of vibegron, compared to tolterodine.
In the two studies, Obgemsa showed a favourable benefit-risk profile in the symptomatic treatment of urgency, increased frequency of urination, and urge urinary incontinence (UUI).
In September last year, Pierre Fabre acquired Swiss biotechnology company Vertical Bio, to gain access to Vertical’s non-small cell lung cancer (NSCLC) treatment VERT-002.
VERT-002 is a monoclonal antibody that targets and degrades c-MET, a known disease driver of NSCLC with MET mutations.
