FDA approves Astellas' Myrbetriq for overactive bladder

The US Food and Drug Administration has approved Japanese drug major Astellas Pharma’s (TYO: 4503) Myrbetriq (mirabegron) to treat adults with overactive bladder (OAB), a condition in which the bladder muscle cannot be controlled, squeezes too often or squeezes without warning.

The decision follows the recent FDA Reproductive Health Drugs Advisory Committee recommendation by a vote of seven for, four no and one abstention that the overall risk/benefit assessment supports approval of mirabegron (YM178) for the treatment of OAB (The Pharma Letter April 10).

“An estimated 33 million Americans suffer from overactive bladder, which is uncomfortable, disrupting and potentially serious,” said Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, adding: “Today’s approval provides a new treatment option for patients with this debilitating condition.”