Urovant Sciences announces FDA approval of Gemtesa 75 mg tablets for the treatment of overactive bladder.

Urovant Sciences announced that the FDA has approved the New Drug Application (NDA) for once-daily 75 mg Gemtesa (vibegron), a beta-3 adrenergic receptor ( beta 3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. This approval marks the first new oral branded OAB medication approved by the FDA since 2012, and it is the first product approval for Urovant Sciences. The FDA’s approval is based on results from an extensive development program involving more than 4,000 OAB patients, including the 12-week double blind, placebo-controlled Phase III EMPOWUR study with a dose of 75 mg and the double blind EMPOWUR long term extension study. These data show that treatment with Gemtesa resulted in statistically significant reductions in daily UUI, micturitions, and urgency episodes?and an increase in the volume voided when compared to placebo in EMPOWUR. The most common adverse reactions of Gemtesa from the double blind, placebo-controlled EMPOWUR study in greater than 2% of patients were headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Gemtesa demonstrated the same rates for the adverse events of hypertension and increased blood pressure as placebo. Urovant is planning to launch Gemtesa in the United States late in the first quarter of 2021.