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
Economic confidence in the eurozone picked up in October from a 10-month low, with broad based improvement across sectors, the results of a survey by the European Commission showed Thursday. The economic confidence index rose unexpectedly to 100.7 in October from 99.9 in the prior month. The score was expected to fall to 99.7. Visa Inc., the world's largest payment card processor, said Wednesday that its fourth quarter profit fell 10% from last year, hurt mainly by a hefty litigation provision even as revenue increased 9%. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue. Stocks saw considerable volatility following the Federal Reserve's monetary policy meeting on Wednesday but maintained a negative bias before closing modestly lower. The losses on the day partly offset the rally seen in the previous session.
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.