Actelion has submitted heart and lung drug macitentan to European health
regulators, the second major step for the drug the Swiss group is positioning
as a viable successor to its current top seller. "The European Medicines
Agency will now start the formal review process," Actelion said on
Thursday. It plans to sell the drug under the brand name Opsumit.
Actelion, which submitted the treatment to the U.S. health regulator a
month ago, issued data last month showing macitentan prolonged overall survival
by more than a third in a clinical trial. The company is banking on macitentan
to replace top-seller Tracleer which, like macitentan, also treats pulmonary arterial
hypertension (PAH) and currently accounts for around 90 percent of group sales.
Tracleer goes off patent from 2015 and faces growing competition from Gilead's
Letairis. Actelion is continuing to prepare macitentan submissions in
Switzerland and major markets around the world, the company said.
Source: Chicago Tribune
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