BRIEF—Urovant submits vibregon for US approval

Urovant Sciences has submitted for approval in the USA for vibegron, for the treatment of people with overactive bladder (OAB).

The submission is supported by data from a pivotal study which met all primary and key secondary efficacy endpoints, and demonstrated a favorable safety profile.

Chief executive Keith Katkin said: “Our NDA submission for vibegron is a significant milestone for our company and brings us one step closer to potentially providing a new oral therapy to a highly dissatisfied market.”

“The symptoms of overactive bladder affect over 30 million people in the USA. Vibegron, if approved next year, would be the first new branded prescription drug for the treatment of OAB in nearly a decade.”