logo
Share SHARE
FONT-SIZE Plus   Neg

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Amgen reported an increase in second-quarter profit, driven by sales of arthritis drug Enbrel and osteoporosis treatments Xgeva and Prolia, and improved margins. Both earnings and sales topped Wall Street estimates. Electronic Arts Inc. (EA) on Thursday reported an increase in profit for the first quarter, reflecting continued strong digital revenues, with both earnings and revenues topping Wall Street estimates. However, shares of the company fell over 4 percent, after having detailed a weak outlook. Redwood... LinkedIn Corp., the world's largest online professional network, said Thursday after the markets closed that its second quarter loss widened sharply from last year, as higher costs and expenses more than offset a 33% increase in revenue. However, the company's quarterly earnings per share, excluding items, came in well above analysts' expectations as did its quarterly revenue.
comments powered by Disqus
Follow RTT