Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

FDA Accepts Actelion's NDA For Macitentan

Actelion Pharmaceuticals Ltd. (ALIOF.PK, ATLN.L) Friday said its New Drug Application, or NDA, for macitentan has been accepted by The U.S. Food and Drug Administration.

Macitentan is registered under the name Opsumit, and is used for the treatment of patients with pulmonary arterial hypertension.

Pulmonary arterial hypertension is a chronic disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual.

In a random, pivotal, long-term Phase III study, Macitentan was found to reduce the risk of morbidity and mortality event over the treatment period versus placebo.

For patients in the 10 mg and 3 mg dose group, risk was reduced by 45 percent and 30 percent, respectively. Meanwhile, nasopharyngitis, headache and anemia were the most common adverse events associated with the use of macitentan.

The review period is expected to last 12 months from the date of NDA submission.

Click here to receive FREE breaking news email alerts for Actelion Ltd., and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
A number of major retailers will be open on Thanksgiving for early Black Friday shopping events. Kohl's department stores will kick off Black Friday sales two hours earlier this year, at 6 p.m. Thanksgiving Day, while Macy's, Bon-Ton and Best Buy will open at the same time. J.C. Penney and Sears... Twitter Inc. has replaced its head of product Daniel Graf just six months after luring him over from Google, according to multiple reports. Graf, previously known for his work leading Google Maps, will retain his vice president of product title and work on Twitter's geolocation features, the Wall... LinkedIn Corp., the world's largest online professional network, said Thursday after the markets closed that its third quarter loss widened slightly from last year, as higher costs and expenses more than offset a 45% 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
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.