CASTRES, France, June 28,
2024 /PRNewswire/ -- The European Commission (EC) has
authorized the marketing of OBGEMSA™ (vibegron) by Pierre Fabre
Laboratories for the symptomatic treatment of overactive bladder
syndrome in adults, a particularly debilitating condition affecting
over 70 million patients* in Europe. In 2022, Pierre Fabre Laboratories
acquired the exclusive license for vibegron from Urovant Sciences
Gmbh for the registration and commercialization of this innovative
treatment in the European Economic Area. The decision of the EC
will be applicable to all EU member states as well as Iceland, Liechtenstein, and Norway. OBGEMSA™ is a trademark owned by
Urovant Sciences.
"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," said Eric
Ducournau, CEO of Pierre Fabre Laboratories.
The decision of the EC follows the favorable opinion issued on
April 25 by the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA). It is based on the results of two pivotal,
multicenter, double-blind, randomized phase 3 studies 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 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. In these studies,
vibegron, as a new selective agonist of beta-3 adrenergic receptors
(AR), demonstrated 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.
Contact:
Laurence MARCHAL
laurence.marchal@pierre-fabre.com
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SOURCE Pierre Fabre