Approval Sought for New Overactive Bladder Drug
Astellas Pharma, Inc., has submitted a New Drug Application to the FDA for mirabegron as a treatment for overactive bladder (OAB).
The drug is a once-daily oral selective beta-3 adrenoceptor agonist discovered and developed by Astellas, which is based in Tokyo and has its U.S. headquarters in Deerfield, Ill. If approved, mirabegron would be the first oral therapy with a new mechanism of action for OAB in nearly 30 years, according to the company. Unlike antimuscarinics, mirabegron works by improving the storage capacity of the bladder. Astellas received approval for mirabegron in Japan in July.
Results from two Phase 3 trials showed that, after 12 weeks of treatment, once-daily mirabegron was associated with significant improvements from baseline in both 24-hour incontinence episodes and micturitions, which were co-primary endpoints. In both trials, mirabegron was well tolerated and was associated with low levels of adverse events.