Almirall: COPD drug approved
27.07.2012 - Spanish drugmaker Almirall S.A.'s inhaled treatment for lung disease COPD has been approved in all EU member states, plus Iceland and Norway.
The approval by the European Commission was expected after the CHMP gave the twice-daily drug a positive opinion in May covering use as a maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD). US approval is expected in July.
Florence-based Menarini Group will have joint commercialisation rights across the majority of EU member states (excluding the UK, the Netherlands and the Nordic countries, where Almirall retains sole marketing rights for the product) as well as Russia, Turkey and other CIS countries under the brand name Bretaris Genuair, while Almirall will market the product in Europe as Eklira Genuair.
Almirall's treatment loosens the muscles around the lungs to improve airflow. COPD makes breathing difficult and is often caused by cigarette smoking, which kills between 200,000 and 300,000 people in Europe a year, Almirall said.