The opinion is a significant step for towards marketing authorisation from the European Commission.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion and recommended the approval of Pierre Fabre Laboratories’ OBGEMSA (vibegron) for overactive bladder syndrome (OAB) in adults.
Vibegron is a potent and selective human beta-3 adrenergic receptor (β3-AR) agonist.
The positive opinion is a significant step towards marketing authorisation from the European Commission for OBGEMSA. The decision impacts all member states of the European Union along with Liechtenstein, Iceland and Norway.
The endorsement is based on positive data from two Phase III studies which demonstrated vibegron’s efficacy and safety over 12 and 52 weeks.
In the pivotal, randomised, multicentre and double-blind studies, Vibegron showed a favourable risk-benefit profile in treating the urgency, increased micturition [urination] and urge urinary incontinence associated with OAB.
The CHMP opinion also considered data from a Phase I study, confirming vibegron’s lack of significant effects on blood pressure or heart rate.
Vibegron is already approved in the US, Japan and the Republic of Korea.
Pierre Fabre Laboratories CEO Eric Ducournau stated: “We are very pleased to have received this positive opinion from the CHMP for OBGEMSA.
“If approved, this innovative therapeutic solution has the potential to help patients suffering from overactive bladder, a condition that is very debilitating in daily life. We have been working in the field of urology for more than 40 years and OBGEMSA is proof of our determination to continue our development in this area.”
Last year, Atara divested its marketing rights to Ebvallo (tabelecleucel) in North America, Asia Pacific and Latin America to Pierre Fabre for $640m. To know more
