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GEN News Highlights : Jun 29, 2012

FDA Clears Astellas’ Myrbetriq for Overactive Bladder

Firm says beta3 adrenergic agonist represents first new class of drug against OAB in 30 years.

FDA approved Astellas Pharma’s Myrbetriq™ (mirabegron) extended release tablets for the treatment of overactive bladder (OAB) associated with symptoms of urge urinary incontinence, urgency, and urinary frequency. The once-daily oral beta-3 adrenergic agonist was discovered by Astellas, and has been tested in over 10,000 patients who either had or hadn’t received prior antimuscarinic therapy for OAB. Myrbetriq was approved in Japan a year ago, and regulatory applications are under review in other countries including Europe.

The Phase III program included three studies which showed that treatment with Myrbetriq resulted in statistically significant improvements in efficacy parameters including incontinence episodes and number of urinations per day. Astellas says the drug is the first oral OAB therapy with a distinct mechanism of action to be approved since the launch of anticholinergic drugs 30 years ago.

Astella’s marketed OAB therapy, Vesicare (solifenacin sucinate) is a muscarinic antagonist that was first approved in the U.S. in 2004.