Almirall's aclidinium approved in Europe for COPD maintenance treatment

Spain’s leading drugmaker, Almirall (ALM: MC) says that the European Commission has granted marketing approval to Eklira/Bretaris Genuair (aclidinium bromide) 322mcg twice daily) in all EU member states, plus Iceland and Norway, as a maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD), following the positive recommendation received from the CHMP in May this year.

Almirall gained 11% to 6.26 euros. in Madrid, on the day it also revealed that its COPD drug, under development with Forest Labs using the trade name Tudorza Pressair, had gained US Food and Drug Administration approval (The Pharma Letter July 24).

“Patients with COPD have a high symptom burden, which can have important effects on their quality of life,” commented Paul W Jones, professor at St George’s Hospital, University of London, UK, and principal investigator of the ATTAIN Phase III study.“The European approval of aclidinium is good news for the healthcare community because improvements observed in health status and symptoms within the trials can finally be translated into benefits for patients in every-day practice”, he added.