Urovant Sciences announces FDA acceptance of NDA for vibegron for the treatment of overactive bladder.
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Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., and Pierre Fabre Médicament. 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.
Ipsen announced that Dysport (abobotulinumtoxinA) has received positive opinion in Europe for the management of urinary incontinence (UI) in adults with neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) (traumatic or non-traumatic) or multiple sclerosis (MS), who are regularly performing clean intermittent catheterization (CIC).
Urovant Sciences announced that the FDA has approved the New Drug Application (NDA) for once-daily 75 mg Gemtesa (vibegron), a beta-3 adrenergic receptor ( beta 3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults.