FDA Advisory Committee Recommends Approval of Mirabegron – Investigational Overactive Bladder Treatment from Astellas
DEERFIELD, Ill., April 5, 2012 – Astellas Pharma US, Inc. (“Astellas”), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the Reproductive Health Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted that the overall risk/benefit assessment supports approval of mirabegron (YM178) for the treatment of overactive bladder (OAB) (Yes: 7, No: 4, Abstain: 1).
Today's committee recommendation, although not binding, will be considered by the FDA as it reviews the New Drug Application (NDA). The FDA is expected to issue an action letter on the mirabegron application by June 29, 2012.
Source: press release, 4/05/12. http://www.astellas.us/docs/us/Advisory_Comm_Press_Release_4-5-12_FINAL_...
Reproductive Health Drugs Advisory Committee Meeting Announcement
April 5, 2012 8:00 a.m. to 4:30 p.m.
The Committee will discuss the benefits and risks of mirabegron (YM178), under New Drug Application (NDA) 202611, submitted by Astellas Pharma Global Development Inc. for the proposed indication of treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Mirabegron is a beta-3-adrenoceptor (AR) agonist and is a new molecular entity. The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy and safety in the treatment of OAB.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Source: FDA.gov. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm291237.htm