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
As Sony Corp. prepares to launch the new PlayStation 4 Pro gaming console on November 10, several new games that are compatible with the console have also been confirmed for launch. Game developers are readying to provide PlayStation 4 Pro support for many games on PS4. Shares of Advaxis Inc. dropped more than 13 percent in pre-market activity before paring losses to just more than 5 percent after the company said that it was not able to complete the second stage of the Phase 2 GOG-0265 trial as designed due to a clinical hold that affected its clinical development programs last year. Dicks Sporting Goods Inc., one of the major sporting good retailers in the U.S., is planning to acquire Golfsmith International Holdings Inc., a specialty retailer with stores in U.S. and Canada, through a bankruptcy auction, Reuters reported. The bid would be worth $70 million and needs approval by a U.S. bankruptcy court.
comments powered by Disqus
Follow RTT