Pierre Fabre overactive bladder med wins approval
CASTRES, France, June 28, 2024 /PRNewswire/ -- The European Commission (EC) has authorized the marketing of OBGEMSA™ (vibegron) by Pierre Fabre Laboratories for the symptomatic treatment of overactive bladder syndrome in adults, a particularly debilitating condition affecting over 70 million patients* in Europe. In 2022, Pierre Fabre Laboratories acquired the exclusive license for vibegron from Urovant Sciences Gmbh for the registration and commercialization of this innovative treatment in the European Economic Area. The decision of the EC will be applicable to all EU member states as well as Iceland, Liechtenstein, and Norway. OBGEMSA™ is a trademark owned by Urovant Sciences.
Pierre Fabre`s Obgemsa (vibegron) Receives Approval In Europe
MARLBOROUGH, Mass., May 13, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), announced today the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for vibegron (GEMTESA®), a beta-3 adrenergic receptor (?3) agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). If approved, vibegron will be the first and only beta-3 agonist for the treatment of men with OAB symptoms receiving pharmacological therapy for BPH. The FDA has set a target action date in Q3 of FY2024, under the Prescription Drug User Fee Act (PDUFA).
CASTRES, France, April 26, 2024 /PRNewswire/ -- Pierre Fabre Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of OBGEMSA™ (vibegron under the international non-proprietary name) for the symptomatic treatment of adult patients with overactive bladder syndrome (OAB). Pierre Fabre Laboratories acquired an exclusive license from Urovant Sciences to register and commercialize vibegron in the European Economic Area in 2022. OBGEMSA™ is a trademark owned by Urovant Sciences GmbH.
CAMBRIDGE, Mass. and BASEL, Switzerland, Sept. 11, 2023 /PRNewswire/ -- Sumitomo Pharma Co., Ltd. companies, Sumitomo Pharma America, Inc. (SMPA) and Sumitomo Pharma Switzerland (SMPS), announced today that the Phase 3 URO-901-3005 clinical study of vibegron (GEMTESA®), a beta-3 adrenergic receptor (?3) agonist, dosed once-daily (75 mg), which is being investigated in men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH), met its co-primary endpoints at Week 12 compared to placebo. The co-primary endpoints include both change from baseline in the average number of micturition (urination) episodes per day and change from baseline in the average number of urgency episodes (the sudden urge to urinate that is difficult to control) per day.
Kyorin and Sumitomo to introduce drug for overactive bladder in Taiwan & other Asian countries
IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced the recent publication of a Phase 1 study of the pharmacokinetic profile of GEMTESA (vibegron) 75mg in the peer-reviewed journal, Clinical Pharmacology in Drug Development. In the study, which involved healthy adults, GEMTESA was administered in a single 75-mg dose as an intact tablet vs. crushed and mixed with applesauce. The results suggest that crushing and administering vibegron with applesauce may be an appropriate consideration for patients with overactive bladder (OAB) and swallowing difficulties.
BASEL, Switzerland, & CASTRES, France--(BUSINESS WIRE)--Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., and Pierre Fabre Médicament today announced they have entered into an exclusive license agreement for Pierre Fabre to register and commercialize vibegron for the treatment of Overactive Bladder (OAB) in the European Economic Area, UK, and Switzerland, with some option territories, which notably include French-speaking countries of Sub-Saharan Africa, Turkey, and certain Eastern European countries. Urovant will retain full rights in the United States and other select markets.
IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced the publication of a new review of data on GEMTESA (vibegron) 75 mg in the peer-reviewed journal, Therapeutics and Clinical Risk Management (https://bit.ly/Vibegron). Titled, ‘An evaluation of the efficacy and safety of vibegron in the treatment of overactive bladder,’ the paper reviews published data from studies conducted over the past three years.