Urovant's Gemtesa (vibegron) Receives the US FDA's Approval for Overactive Bladder
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
Ref: GLOBE NEWSWIRE | Image: Yahoo Finance
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