FDA advisory panel backs Astellas OAB drug mirabegron

The US subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) said last week that the Reproductive Health Drugs Advisory Committee of the US Food and Drug Administration voted seven for, four no and one abstention that the overall risk/benefit assessment supports approval of mirabegron (YM178) for the treatment of overactive bladder (OAB).

The majority vote came despite the drug being linked to high blood pressure and other side effects. Panel members have recommended that Astellas should conduct follow-up studies to better understand the side effects. The committee recommendation, although not binding, will be considered by the FDA as it reviews the New Drug Application. The FDA is expected to issue an action letter on the mirabegron application by June 29, 2012.

Mirabegron is a once daily oral selective B3-adrenoceptor agonist discovered and developed by Astellas. Mirabegron has been studied extensively in more than 10,000 individuals over the last 10 years.