Urovant Sciences (Nasdaq: UROV) announced the U.S. Food and Drug Administration (FDA) approval of 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. This approval marks the first new oral branded OAB medication approved by the FDA since 2012, and it is the first product approval for Urovant Sciences.
“The FDA’s approval of Gemtesa is an important milestone for the tens of millions of patients living with overactive bladder and for Urovant, as it is our first drug approval. We look forward to launching Gemtesa in the coming months and believe that it will provide a compelling alternative for the many patients suffering from the burden of an overactive bladder. We also remain committed to bringing more new therapies to market that address unmet medical needs of patients suffering from urologic diseases,” said Jim Robinson, president and chief executive officer of Urovant Sciences.
“The clinical data for once-daily 75 mg Gemtesa demonstrated clear efficacy on the key symptoms of OAB by reducing urinary frequency, urge urinary incontinence, and urgency. In addition, data specifically showing reduction in urgency episodes are included in the Prescribing Information of Gemtesa, which is unique among currently-available OAB treatments. Urgency episode reduction data are particularly relevant for OAB patients and their health care providers, as they show Gemtesa’s direct impact on a hallmark symptom of the condition,” said Cornelia Haag-Molkenteller, M.D., Ph.D., chief medical officer of Urovant Sciences. “By successfully treating clinical symptoms, Gemtesa may allow patients to overcome the devastating impact that OAB can have on their daily lives.”
Gemtesa is an oral, once-daily tablet containing 75 mg of vibegron, a small-molecule β3 agonist which helps relax the detrusor bladder muscle so that the bladder can hold more urine, thereby reducing symptoms of OAB.
“Gemtesa is the first beta 3-agonist available as a once-daily pill which does not require dose titration,” said David Staskin, MD, clinical trial investigator and a leading urologist with St. Elizabeth’s Medical Center in Boston. “Notably, Gemtesa did not have any increase in the adverse event of hypertension compared to placebo in the key EMPOWUR study and has no interactions with medications metabolized by CYP2D6, which is important since many common medications are metabolized by CYP2D6.”
The FDA’s approval is based on results from an extensive development program involving more than 4,000 OAB patients, including the 12-week double blind, placebo-controlled Phase 3 EMPOWUR study with a dose of 75 mg and the double blind EMPOWUR long term extension study.1 These data show that treatment with Gemtesa resulted in statistically significant reductions in daily UUI, micturitions, and urgency episodes and an increase in the volume voided when compared to placebo in EMPOWUR.
The most common adverse reactions of Gemtesa from the double blind, placebo-controlled EMPOWUR study in ≥2% of patients were headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Gemtesa demonstrated the same rates for the adverse events of hypertension and increased blood pressure as placebo.
