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
Can a washing machine explode just like a bomb? A lawsuit filed in the federal court in New Jersey alleged that there was loud noise and damage to garage wall as the washing machine went off with a violent boom. Samsung is facing federal class action lawsuit from customers. There were similar reports... German lender Commerzbank AG said Thursday that it will cut almost 10,000 jobs, stop paying dividends for the time being and merge two big units as part of a restructuring to become profitable on a sustainable basis by 2020. The bank, Germany's second largest, said that to cover its restructuring costs in the region of 1.1 billion euros, it will cease dividend payments for the time being. Apple Inc. has repeatedly assured customers of its commitment to privacy and said that iMessage conversations are safe. However, Apple's iMessage logs the phone numbers typed by users for a text conversation and shares this information with law enforcement when compelled by court order, according to news site "The Intercept."
comments powered by Disqus
Follow RTT