FDA committee recommends approval of OAB agent

The FDA’s Reproductive Health Drugs Advisory Committee recently voted that the overall risk/benefit assessment supports approval of the investigational agent mirabegron for the treatment of overactive bladder.

The committee’s recommendation, while not binding, will be considered by the FDA as it reviews the new drug application for the agent. The FDA is expected to issue an action letter on the mirabegron application by June 29, 2012.

Mirabegron is a once-daily oral selective β3-adrenoceptor agonist discovered and developed by Astellas Pharma U.S., Inc. Mirabegron has been studied in more than 10,000 individuals over the last 10 years, according to Astellas.

"If approved, mirabegron will offer patients and physicians the first new oral mechanism of action in OAB treatment since the launch of the first anticholinergic agent 30 years ago," said Steven Ryder, MD, of Astellas Pharma.

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