LONDON (Reuters) – European regulators have recommended approval of Swiss firm Actelion’s new pulmonary arterial hypertension drug Opsumit and a novel antidepressant called Brintellix from Denmark’s Lundbeck.
The green light for Opsumit comes hard on the heels of its approval in the United States last week and buttresses Actelion’s position as a leading player in treating pulmonary arterial hypertension (PAH).
Opsumit is a successor to Actelion’s established medicine Tracleer, which loses patent protection in 2015.
PAH is a condition characterized by high blood pressure in the arteries connecting the heart to the lungs.
Opsumit will compete with, among others, Gilead Sciences’ Letairis, which is sold in Europe by GlaxoSmithKline under the brand name Volibris.
Brintellix is an equally important new drug for Lundbeck, which hopes the antidepressant will provide a new source of revenue as its existing antidepressant, Cipralex, sold as Lexapro in the United States and Japan, comes off patent.
The drug was approved in the United States last month and will be co-marketed with Takeda Pharmaceutical.
The recommendations for marketing approval by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) were announced on Friday, and its opinions are normally endorsed by the European Commission within a couple of months.
Lundbeck said it expected Brintellix would be available to patients in the first markets in the European Union during the first half of 2014.
(Reporting by Ben Hirschler; Editing by Mark Potter)
- Pharmaceuticals & Drug Trials