Astellas submits mirabegron NDA in Japan

Astellas Pharma Inc. (Tokyo:4503) disclosed in its quarterly financial results that it submitted an NDA in Japan for mirabegron ( YM178) to treat urinary frequency, urinary incontinence or urgency associated with overactive bladder. The adrenergic receptor beta 3 (ADRB3) agonist is in Phase III testing for the indication in the EU and the U.S., with an NDA submission planned for this year.

The company also said it suspended U.S. Phase II testing of ASP6183 to treat ovarian cancer after a review of new and existing preclinical data. The product is an antibody that binds to human chondrolectin. ...