FDA committee recommends approval of Astellas drug

The Reproductive Health Drugs Advisory Committee of the U.S. Food and Drug Administration voted recommend approval of Astellas Pharma’s bladder control drug mirabegron, the Deerfield-baseed company said.

The committee’s recommendation, although not binding, will be considered by the FDA as it reviews Astella’s New Drug Application, the company said in a release. The FDA is expected to issue an action letter on the mirabegron application by June 29.

Mirabegron is a once daily oral medication discovered and developed by Astellas. Mirabegron has been studied extensively in more than 10,000 individuals over the last 10 years.

“We are pleased with the committee’s recommendation, which marks an important step in bringing a new treatment option to the more than 42 million Americans living with overactive bladder,” said Steven Ryder, M.D., president, Astellas Pharma Global Development. “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. Mirabegron and other pipeline products are part of Astellas’ commitment to advancing urological health.”