First oral new drug for bladder overactive disorder (OAB) in nearly 10 years! Beta 3 epinephrine-estory agonist Gemtesa is FDA approved!

December 24, 2020 // -- Urovant Sciences recently announced that the U.S. Food and Drug Administration (FDA) has approved a daily 75 mg Gemtesa (vibegron, Vibergron) for the treatment of patients with urgency urinary incontinence (UUI), uremia, and frequent urethra (OAB).
, Gemtesa marks the first FDA-approved oral brand of OAB since 2012, and the first product approval for Urovant Sciences.
Gemtesa is an oral, once-a-day tablet containing 75mg vibegron, a small molecule beta-3 epinephrine-enabled agitating agent that helps relax the forced urine muscle and allows the bladder to hold more urine, thereby reducing OAB symptoms.
OAB (Photo: powerofpositivity.com) Gemtesa is the first daily beta-3-agonist that does not require dose titration, and it is important to note that in the critical Phase 3 EMPOWUR study, Gemtesa did not increase adverse events of hypertension compared to placebos and did not interact with CYP2D6 metabolized drugs, which is important because many common drugs are metabolized by CYP2D6.
this approval is based on the results of an extensive clinical development project involving more than 4,000 OAB patients, including a key 12-week double-blind, placebo-controlled Phase 3 EMMOWUR study (Gemtesa dose of 75 mg per day), double-blind EMOWUR long-term expansion study.
EMPOWUR study, data showed that patients in the Gemtesa treatment group had significantly fewer UUI, urination and emergency seizures per day and increased urination compared to the placebo group.
study, the most common adverse reactions ≥ 2 percent of patients were headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infections.
Gemtesa showed the same incidence of high blood pressure and elevated blood pressure as placebos.
. Jim Robinson, president and chief executive officer of Urovant Sciences at vibegron Chemical Structures (photo source: newdrugapprovals.org), said: "FDA approval of Gemtesa is an important milestone for tens of millions of OAB patients and Urovant because it is our first drug approval.
we look forward to bringing Gemtesa to market in the coming months and believe it will provide a compelling alternative for many OAB patients.
continue to work to introduce more new therapies to the market to address unsealed medical needs in patients with urinary system diseases.
Dr Cornelia Haag Molkenteller, Chief Medical Officer, Urovant Sciences, said: "Clinical data show that 75mg Gemtesa once a day has significant effects on key OAB symptoms by reducing urine frequency, urgent urinary incontinence, and urgency.
addition, Gemtesa's prescription information contains data that clearly show a decrease in emergencies in the OAB treatments currently available.
emergency reduction data are particularly relevant to OAB patients and their healthcare providers because they show that Gemtesa has a direct impact on the disease's signature symptoms.
by successfully treating clinical symptoms, Gemtesa allows patients to overcome the devastating effects of OAB on their daily lives.
Origin: Urovant Sciences Announces U.S. FDA approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients withActive OverBladder (OAB)