Pierre Fabre’s vibegron gains CHMP positive opinion for OAB
Clinical ResultDrug ApprovalPhase 3Phase 1
Preview
Source: Pharmaceutical Technology
Vibegron has shown a favourable risk-benefit profile in treating urgency. Credit: SewCreamStudio/Shutterstock.com.
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.
See Also:
Corcept Therapeutics gets grant for treating antipsychotic-induced weight gain with miricorilant
Preview
Source: Pharmaceutical Technology
Merus gets grant for treatment of CLEC12a positive cancer with bispecific antibody
Preview
Source: Pharmaceutical Technology
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.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Targets
Chat with Hiro
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.