EU agency backs new drugs from Actelion and Lundbeck
London: 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.
More from India
More from World
More from Sports
More from Entertaiment
- Dausa car crash: Hema Malini injured, child killed; MP's driver booked for over speeding
- Islamic State trying to gain foothold in Pakistan-occupied Kashmir: Army
- UPSC announces Civil Services Examination 2014 results; women bag top four positions
- Kapil Sharma shares pic with Salman Khan; ‘Comedy Nights...’ to go off air
- Wimbledon: Novak Djokovic, Maria Sharapova cruise into last 16