Astellas Pharma says that the US Food and Drug Administration has accepted the Japanese drugmaker's New Drug Application for its bladder drug mirabegron.
The company has been given an action date of June 29, 2012 and it noted that a similar letter from the European Medicines Agency confirming the start of the review procedure has been received. Astellas is seeking approval for mirabegron for the indication of overactive bladder associated with urgency, urinary frequency, and urge urinary incontinence.
Approved in Japan in July, as Betanis, mirabegron is a first-in-class beta-3 adrenoceptor agonist and the once-daily tablet facilitates bladder filling and storage of urine. Astellas already markets an OAB treatment, Vesicare (solifenacin).
Meantime, Astellas has linked up with Japan's Riken Brain Science Institute to develop novel drug targets for Alzheimer's disease. The five-year agreement will focus on "deciphering the pathogenic mechanisms" underpinning the disease and developing 'revolutionary new drugs".