The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020. In addition, the FDA has communicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application.
“FDA acceptance of our NDA for vibegron for the treatment of patients with OAB represents another important milestone for Urovant, and we look forward to working with the FDA during the NDA review period,” said Dr. Cornelia Haag-Molkenteller, Chief Medical Officer of Urovant Sciences.
“The symptoms of overactive bladder affect over 30 million people in the United States. Vibegron, if approved, would be the first new branded prescription drug for the treatment of OAB in nearly a decade and would offer these suffering patients another potential treatment option.”
Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions.
The Company’s lead product candidate, vibegron, is an oral, once-daily small molecule beta-3 agonist that is being evaluated for overactive bladder (OAB). Urovant Sciences reported positive data from the vibegron 12-week, Phase 3 pivotal EMPOWUR study and demonstrated favorable longer-term efficacy, safety, and tolerability in a 40-week extension study. The Company submitted a New Drug Application to the FDA seeking approval of vibegron for the treatment of patients with OAB in December 2019.
Vibegron is also being evaluated for treatment of OAB in men with benign prostatic hyperplasia (OAB+BPH) and for abdominal pain associated with irritable bowel syndrome (IBS). Urovant’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy.
Urovant Sciences, a subsidiary of Sumitovant Biopharma Ltd., which is a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., intends to develop novel treatments for additional urologic diseases.
Source: Company Press Release