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
Automaker General Motors Co. reported Tuesday a decline in its second-quarter profit on charges and weak vehicle sales. North America and International Operations reported lower volume, partly offset by growth in South America. The company further said it is on track to meet financial commitments for 2017. Taiwanese technology giant Foxconn's Technology Group, which assembles Apple Inc.'s iPhones, is nearing a decision to invest in Wisconsin for producing display panels, the Wall Street Journal reported, citing people familiar with the matter. The company is said to hold an event in Washington, D.C., as soon as this week to discuss U.S. investment plans. Grab, the Singapore-based ride hailing company and Uber's biggest Asian rival, said Monday that Chinese ride-sharing company Didi Chuxing and Japan's SoftBank Group Corp. will invest a combined $2 billion to lead Grab's new financing round.
comments powered by Disqus
Follow RTT