ZURICH |
Fri Dec 14, 2012 1:43am EST
ZURICH (Reuters) – Biotechnology association Actelion pronounced on Friday a U.S. health regulator supposed a acquiescence on a company’s macitentan drug, meant to provide patients with a potentially life-threatening lung condition.
Actelion submitted a focus for a drug for a diagnosis of pulmonary arterial hypertension, a condition characterized by abnormally high blood vigour in a arteries of a lungs, in October.
The Swiss association is banking on macitentan to reinstate Tracleer, that also treats pulmonary arterial hypertension (PAH) and now accounts for around 90 percent of organisation sales, though goes off obvious from 2015 and faces flourishing foe from U.S. opposition Gilead’s Letairis.
The examination duration of a U.S. regulator, a Food and Drug Administration, is approaching to final 12 months, Actelion said.
(Reporting by Martin de Sa’Pinto; Editing by Muralikumar Anantharaman)
Source: Health Medicine Network