Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Astellas Pharma Says FDA Advisory Committee Recommends Approval Of Mirabegron

Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (ALPMY.PK, ALPMF.PK), announced 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 or NDA, the company said. The FDA is expected to issue an action letter on the mirabegron application by June 29, 2012.

Mirabegron is a once daily oral selective B3-adrenoceptor agonist discovered and developed by Astellas. Mirabegron has been studied extensively in more than 10,000 individuals over the last 10 years.

Mirabegron uses a distinct mechanism of action versus antimuscarinics, the current treatment standard. Antimuscarinics work by binding to muscarinic receptors in the bladder and inhibiting involuntary bladder contractions. Mirabegron works by stimulating the B3 receptors in the detrusor muscle of the bladder, causing relaxation of the bladder muscle during the storage phase of the micturition (urination) cycle. This improves the storage capacity of the bladder without diminishing bladder contraction during bladder voiding.

Register
To receive FREE breaking news email alerts for Astellas Pharma Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Kraton Performance Polymers, Inc. (KRA), Wednesday reported second-quarter net income of $11.1 million or $0.33 per share, up from $3.8 million or $0.12 per share last year. Adjusted earnings improved to $0.46 per share from $0.15 per share last year. Revenues for the quarter dropped to $323.8... Organic grocer Whole Foods Market, Inc. said Wednesday after the markets closed that its third quarter profit rose 6.3% from last year, as same-store sales increased 3.9%. The company's quarterly earnings per share also came in above analysts' expectations, but its quarterly sales fell shy of analyst' forecast. Micro-blogging site Twitter Inc said Tuesday after the markets closed that its second quarter loss widened from last year, hurt mainly by stock-based compensation expense, even as revenue more than doubled thanks to growth in advertising. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.