23 December 2020 - Sumitovant Biopharma today announced that Urovant Sciences has received U.S. FDA approval of its new drug application for once daily 75 mg Gemtesa (vibegron), a beta-3 adrenergic receptor agonist, for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Gemtesa is the first oral branded medication for overactive bladder to be approved by the FDA since 2012, and it is the first product approval for Urovant Sciences.