EU agency backs new drugs from Actelion and Lundbeck

Reuters

LONDON, Oct 25 (Reuters) - European regulators haverecommended approval of Swiss firm Actelion's newpulmonary arterial hypertension drug Opsumit and a novelantidepressant called Brintellix from Denmark's Lundbeck.

The green light for Opsumit comes hard on the heels of itsapproval in the United States last week and buttressesActelion's position as a leading player in treating pulmonaryarterial hypertension (PAH).

Opsumit is a successor to Actelion's established medicineTracleer, which loses patent protection in 2015.

PAH is a condition characterised by high blood pressure inthe 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 ofrevenue as its existing antidepressant, Cipralex, sold asLexapro in the United States and Japan, comes off patent.

The drug was approved in the United States last month andwill be co-marketed with Takeda Pharmaceutical.

The recommendations for marketing approval by the EuropeanMedicine Agency's Committee for Medicinal Products for Human Use(CHMP) were announced on Friday, and its opinions are normallyendorsed by the European Commission within a couple of months.

Lundbeck said it expected Brintellix would be available topatients in the first markets in the European Union during thefirst half of 2014.

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