FDA approves Gemtesa for OAB

24 December 2020

The US Food and Drug Administration has approved the New Drug Application (NDA) for once-daily Gemtesa (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults, from Urovant Sciences (Nasdaq: UROV).

This authorization marks the first new oral branded OAB medication cleared by the FDA since 2012, and it is the first product approval for Urovant Sciences. Vibegron is already approved and marketed in Japan, the home of Urovant’s about to be parent company Sumitomo Dainippon Pharma (TYO: 4506), but marketed by Kyorin Pharmaceutical (TYO: 4569).

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