Shots:

• The approval is based on P-III EMPOWUR and EMPOWUR long term extension study that involves assessing Gemtesa (75mg- qd) vs PBO in ~4000 patients with OAB for 12wks.
• The study resulted in reductions in daily UUI- micturitions- and urgency episodes and an increase in the volume voided
• Gemtesa is a small-molecule β3 adrenergic receptor agonist therapy that relaxes the detrusor bladder muscle so that the bladder can hold more urine- thus reducing symptoms of OAB. Gemtesa is the first oral branded FDA’s approved OAB medication since 2012- and it is the first product approval for Urovant Sciences

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