Pierre Fabre Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion recommending approval of OBGEMSA (vibegron under the international non-proprietary name) for the symptomatic treatment of adult patients with overactive bladder syndrome (OAB).
Vibegron is a novel, potent, and selective human beta-3 adrenergic receptor (β3-AR) agonist. Beta receptors are found throughout the body, but β3-ARs are predominantly found on human detrusor smooth muscle. β3-ARs agonists bind to and activate beta-3 receptors on the detrusor muscle, leading to relaxation of the detrusor muscle to increase vesical capacity and to reduce OAB symptoms.