ZURICH (Reuters) – Biotechnology company Actelion said on Friday the U.S. health regulator accepted a submission on the company’s macitentan drug, meant to treat patients with a potentially life-threatening lung condition.
Actelion submitted the application for its drug for the treatment of pulmonary arterial hypertension, a condition characterized by abnormally high blood pressure in the arteries of the lungs, in October.
The Swiss company is banking on macitentan to replace Tracleer, which also treats pulmonary arterial hypertension (PAH) and currently accounts for around 90 percent of group sales, but goes off patent from 2015 and faces growing competition from U.S. rival Gilead’s Letairis.
The review period of the U.S. regulator, the Food and Drug Administration, is expected to last 12 months, Actelion said.
(Reporting by Martin de Sa’Pinto; Editing by Muralikumar Anantharaman)
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Actelion says FDA accepts lung drug for review
