product approval introduction

Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)

Urovant Sciences, Inc (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg 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. Read more.

Source: BioSpace, December 23, 2020

drugs for overactive bladder (OAB)

First Big Test Approaches for Urovant

Investors who backed Urovant’s $140m flotation last September will soon find out whether the money was well spent. Before the end of March the company will release topline pivotal data on the overactive bladder project vibegron, a β3-adrenergic receptor agonist licensed from Merck & Co, and a positive result should allow regulatory filings to follow.  It seems likely that the trial will hit: Merck successfully conducted a large phase IIb study of vibegron a few years ago, and a similar compound is already on the market in the shape of Myrbetriq, which has been sold by Astellas since 2011. This well-established product has only four years of US patent life left, so if Urovant has any chance of building vibegron into a similarly large product it needs to prove that its contender is both safer and more effective.   Read more.

Source: Evaluate, March 12, 2019

drugs for overactive bladder (OAB)

Urovant Starts Pursuit of Astellas’ Overactive Bladder Drug Myrbetriq with New Phase 3 Trial

A little later than expected, Roivant group company Urovant has started its confirmatory phase 3 program for overactive bladder (OAB) drug vibegron, originally licensed from Merck & Co.  The pivotal trial—which was originally expected to get underway last year—will involve around 1,400 adults with symptoms of OAB such as urge urinary incontinence, urgency, and urinary frequency, according to Urovant.  The drug already has positive phase 2b and phase 3 data in hand, so if the latest trial is positive Urovant should be able to move ahead with regulatory filings. If approved, it could become a direct competitor to Astellas’ Myrbetriq (mirabegron), the first beta3-adrenergic agonist to reach the market for OAB. And that could present a big commercial opportunity: Astellas reported sales of its drug rose 30% to 93.1 billion yen ($876 million) in the nine months to end-January 2018 with take-up driven by greater tolerability than the widely used antimuscarinic OAB drug class. Read more.

Source: Fierce Biotech, March 28, 2018