logo
Share SHARE
FONT-SIZE Plus   Neg

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Tesla Motors Inc. (TSLA) has launched a new referral program for owners and new buyers of its Model S, as the electric car maker aims to boost sales with the latest marketing strategy. Tesla's referral program offers new buyers a discount of $1,000 if they order a new Model S using the referral link... Marriott reported a 25 percent jump in quarterly profit, topping analysts' estimates, as customers flocked to its hotel properties, driving up occupancy and room rates. The hotel chain provided weak earnings outlook for the current quarter, but lifted its expectations for 2015... Social networking giant Facebook, Inc. said Wednesday after the markets closed that its second quarter profit fell 9% from last year, as higher costs and expenses more than offset a 39% increase in revenue. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue.
comments powered by Disqus
Follow RTT