Actelion says FDA accepts lung drug for review
ZURICH (Reuters) - Biotechnology company Actelion said on Friday the U.S. health regulator has agreed to evaluate the company's macitentan drug for the treatment of patients with a potentially life-threatening lung condition.
Actelion in October submitted an application for the drug for the treatment of pulmonary arterial hypertension (PAH), a condition characterized by abnormally high blood pressure in the arteries of the lungs.
The Swiss company is banking on macitentan to replace Tracleer, which also treats PAH, but goes off patent from 2015 and faces growing competition from U.S. rival Gilead's Letairis.
The review period of the U.S. the Food and Drug Administration is expected to last 12 months, Actelion said.
Shares in Actelion fell 1.3 percent to 45.73 francs by 1108 GMT, compared to a flat European healthcare index, with some investors disappointed that the drug, which the company will market as Opsumit, did not receive a priority review.
"Even though Opsumit did not receive priority review status the news of (new drug application) acceptance is positive and places the drug's launch to end of FY13," Vontobel analyst Andrew Weiss said in a note.