FDA advisory committee recommends approval for Astellas overactive bladder drug

DEERFIELD, Ill. — A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.

The drug maker announced that the FDA Reproductive Health Drugs Advisory Committee voted 7-4 with one abstention that its assessment of the risks and benefits of the drug YM178 (mirabegron) supported the drug's approval.

The FDA is not required to follow the recommendations of advisory committees, but usually does. The agency is expected to decide whether or not to approve the drug by June 29.


Interested in this topic? Sign up for our weekly DSN Collaborative Care e-newsletter.