Urovant Archives - Medical Design Sourcing

AUA2021: Gemtesa effective in OAB wet and dry

Urovant’s Gemtesa (vibegron) was the subject of two presentations at the Annual Meeting of the American Urological Association (AUA2021).

The first explained that vibegron is effective in patients with ‘dry’ overactive bladder (OAB) based on a post-hoc analysis of the pivotal EMPOWUR trial. The second presentation explained that vibegron had a negligible impact on ambulatory blood pressure in a randomized, double-blind, placebo-controlled study.

Vibegron, a beta-3 agonist, stands out in a market of overactive bladder drugs that are primarily antimuscarinics. “There’s only one other beta-3 agonist on the market,” said Dr. David Staskin, who was the international lead investigator in the EMPOWUR trial.

The drug is also unique in that its label includes data on urgency associated with OAB. “It’s the first time [urgency] has ever been in a package insert for any overactive bladder drug,” said Staskin, who is also an associate professor of urology at Tuft…

A closer look at Urovant’s vibegron blood pressure study

In recent years, regulators including FDA have increased their focus on the potential of drugs to cause blood pressure increases. To that end, the agency asked Urovant (Irvine, California) to study the impact of the beta-3 adrenergic receptor agonist vibegron on blood pressure.

The study, recently published in the Journal of Urology, found no significant change in blood pressure among either vibegron or placebo recipients. There were 96 patients in the vibegron group. Another 101 received placebo. “The good news was that the changes in blood pressure were trivial — on average less than one millimeter of mercury,” said Dr. Michael A. Weber, a professor of medicine at SUNY Downstate College of Medicine in New York, who was involved in the study.

Weber recently summarized the results at the Annual Meeting of the American Urological Association.

FDA approved vibegron in late 2020. In addition, the agency approved another beta-3 adrenergic receptor agonist…

Urovant shares positive data at the annual meeting of the American Urological Association

Urovant Sciences (Irvine, California) is upbeat about the prospects of beta-3 adrenergic receptor agonist Gemtesa (vibegron) in treating overactive bladder (OAB). This week, the drug was featured in two presentations at the virtual American Urological Association (AUA) Annual Meeting.

Historically, the primary treatment for OAB involved a type of anticholinergics known as muscarinic receptor antagonists.

In 2012, Astellas Pharma (TYO: 4503) won FDA approval for Myrbetriq (mirabegron), the first beta-3 adrenergic receptor agonist for OAB to hit the market. More recently, Urovant, a subsidiary of Sumitovant Biopharma Ltd., won FDA approval for Gemtesa (vibegron), another beta-3 adrenergic receptor agonist, which became commercially available in April.

Anticholinergics used for OAB can have bothersome side effects such as dry mouth and constipation, said Dr. Cornelia Haag-Molkenteller, chief medical officer at Urovant. Such side effects lead many patients…