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
Online travel agency Priceline Group, Inc. on Wednesday reported an increase in profit for the first quarter from last year on double-digit revenue growth amid higher travel and room night bookings. Both adjusted earnings per share and quarterly revenues topped analysts' expectations. However, the company provided financial outlook for the second quarter below analysts' estimates. Time Warner Inc. (TWX) reported a profit for its first quarter ended March 31, 2016 that increased about 25 percent from the prior year. Revenues increased 3% and adjusted operating income grew 11% due to strong growth across all its operating divisions. It reaffirmed its 2016 adjusted earnings per share outlook. German telecom giant Deutsche Telekom AG reported Wednesday that its first-quarter net profit quadrupled on hefty stake sale gain. Revenues also increased on US strength, while domestic revenues were weak.
comments powered by Disqus
Follow RTT