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The first oral new drug for overactive bladder (OAB) in the past 10 years!
The first oral new drug for overactive bladder (OAB) in the past 10 years! Beta3 adrenergic receptor agonist Gemtesa is launched in the United States!
Urovant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies for urinary system diseases. Recently, the company announced the launch of Gemtesa (vibegron) 75mg tablets in the US market. The drug is taken orally once a day for the treatment of bladder with symptoms of urgency urinary incontinence (UUI), urgency, and frequent urination. Patients with hyperactivity disorder (OAB).
Adult patients with OAB may experience symptoms such as UUI, urgency, and frequent urination, which have a great impact on daily activities. Gemtesa is an oral, once-a-day tablet, each containing 75mg vibegron, which is a small molecule β3 adrenergic receptor agonist, which relaxes the detrusor muscle and enables the bladder to hold more urine, thereby Reduce the annoying symptoms of OAB.
Gemtesa was approved by the US FDA in December 2020, marking the first new oral brand OAB drug approved by the agency since 2012. In addition, Gemtesa is the first and only β3 agonist with urinary urgency data and no blood pressure warning on the label. Clinical data showed that in the 12th week of treatment, compared with placebo, Gemtesa significantly reduced all three key OAB symptoms, and there was no known cognitive decline associated with β-3 agonists.
Gemtesa’s prescribing information contains data that clearly shows a reduction in urinary urgency, which is unique among currently available OAB drugs. Data on the reduction of urinary urgency events are particularly relevant for OAB patients and their healthcare providers, because these data indicate that Gemtesa has a direct impact on the hallmark symptoms of the disease. By successfully treating clinical symptoms, Gemtesa can enable patients to overcome the destructive effects of OAB on their daily lives.
OAB (Image source: powerofpositivity.com)
Gemtesa is the first once-daily β3-agonist that does not require dose titration. It is worth noting that in the pivotal Phase 3 EMPOWUR study, Gemtesa did not increase the adverse events of hypertension compared with placebo, and was metabolized with CYP2D6 The drug does not interact, which is important because many common drugs are metabolized by CYP2D6.
Gemtesa's regulatory 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 EMPOWUR study (Gemtesa dose is 75mg once daily), Double-blind EMPOWUR long-term extended study. In the EMPOWUR study, data showed that compared with the placebo group, patients in the Gemtesa treatment group had significantly reduced daily UUI, urination and emergency attacks, and increased urination. In this study, the most common adverse reactions that occurred in ≥2% of patients were headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Gemtesa showed the same rate of adverse events of hypertension and elevated blood pressure as placebo.
vibegron chemical structure (picture source: newdrugapprovals.org)
Jim Robinson, President and CEO of Urovant Sciences, said: "Urovant is pleased to bring Gemtesa to patients and healthcare providers who need new treatment options to solve the annoying symptoms of OAB. The launch of this product is an important one for Urovant. A milestone because we are bringing our first product to the market. This is also an important moment for the entire urology community, because Gemtesa is the first new oral OAB drug to enter the market in the past decade."
Scott a. MacDiarmid, MD, a urologist at the Alliance Urology Specialists, said: "The launch of Gemtesa is an important step forward, providing patients with a safe and effective option for the treatment of OAB symptoms. Gemtesa will enable Gemtesa. We can provide a patient-centered treatment experience and bring a new β-3 agonist to the forefront of OAB treatment."