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New Medicines

GemtesaOveractive bladder with symptoms of urge urinary incontinence (UUI), urgency and frequency - second-line as monotherapy or as an add-on to anticholinergic therapy

Information

Gemtesa
New molecular entity
Urovant Sciences
Urovant Sciences

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Launched
Jul 21In the US, Urovant has teamed up with Sunovion to market Gemtesa. While Urovant focus on promotion to specialists, Sunovion will promote the drug to primary care physicians [20].
Apr 21Launched in the US [19]
Dec 20Approved in the US for "the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults" [18].
Jan 20Urovant has submitted a New Drug Application to the U.S. FDA seeking approval of once-daily 75mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency [15].
Dec 19In its latest 10K form, Urovant comments that according to its agreement with Merck, it is obligated to use commercially reasonable efforts to develop and commercialize a licensed product in the US and EU by certain dates, subject to requisite governmental authorisations. Additionally, after obtaining regulatory approval of a licensed product in a given country, it is obligated to use commercially reasonable efforts to commercialise and maximize the value of such licensed product in such country. No specific plans for EU filing described [14].
Sep 19Urovant expected to file for FDA approval during financial year 2019/20 [13]
Dec 18Approved in Japan (Sep 18). Plans to file in US early 2020 [11]
Jun 17Urovant Sciences aquired global rights, excluding Japan and certain Asian territories, for the development and commercialisation of vibegron from Merck. [11]

Category

Agonist of beta-3 adrenergic receptors which enhances bladder relaxation
Detrusor overactivity is the second most common cause of female urinary incontinence. [3]
Overactive bladder with symptoms of urge urinary incontinence (UUI), urgency and frequency - second-line as monotherapy or as an add-on to anticholinergic therapy
Oral

Trial or other data

Sep 21Post-hoc subgroup analyses from PIII EMPOWUR study (n=214) find no statistically significant or clinically relevant differences in mean daytime and 24-hour ambulatory systolic or diastolic BP or HR after 28 days of treatment with vibegron vs placebo [21].
Mar 20Data from PIII EMPOWUR trial published online in the J. of Urology. [16]
Mar 19 Urovant announce PIII EMPOWUR trial meets co-primary endpoints at week 12, decreasing daily urge urinary incontinence and decreasing daily microuritions vs placebo. Full data will be presented at an upcoming medical conference [13].
Mar 18Pivotal, randomised, double-blind, placebo- and active comparator-controlled international PIII clinical trial EMPOWUR initiated. The EMPOWUR trial will evaluate safety and efficacy of vibegron in men and women with symptoms of overactive bladder. The study is expected to enroll approximately 1,400 pts who will be randomided to one of three groups for a 12-week treatment period: oral vibegron 75 mg once daily, oral placebo once daily or oral tolterodine ER 4 mg once daily. Eligible pts completing the initial 12-week blinded assessment can enroll in a 40-week double-blind extension study to evaluate the safety of longer-term treatment. The co-primary efficacy endpoints of the study are; change from baseline in the average number of micturitions per 24 hours and change from baseline in the average number of urge urinary incontinence (UUI) episodes per 24 hours in pts with an average of ≥ 1 UUI episodes per day prior to treatment.[10]
Dec 17Results are available for PIII study (NCT01314872) [8].
Jan 17No further development reported [7].
Jan 16No progress to PIII studies in EU or US, but PIII in Japan [5].
Oct 13A one-year extension trial to PIIb (NCT01314872) study completes. Patients who completed part one of the study were screened for the extension to assess the long-term safety and efficacy of MK 4618 [4].
Jan 11 2-part phase IIb worldwide trial to assess the safety and efficacy of once daily low-mid-high doses of MK 4618 compared with tolterodine ER in 1295 patients with overactive bladder (NCT01314872). [2]