Almirall has submitted a marketing authorisation application to the European Medicines Agency for aclidinium bromide for the treatment of chronic obstructive pulmonary disease.
The filing is based on efficacy data from a Phase III programme in which patients received aclidinium bromide 400 mcg or 200 mcg twice daily (BID) or placebo. In the studies, the former dosage produced significant improvement in morning pre-dose (trough) FEV1 versus placebo at week 12 and 24.
Eduardo Sanchiz, chief executive of the Spanish drugmaker, said the submission is an important milestone for Almirall and chief scientific officer Bertil Lindmark added that aclidinium BID "has shown to provide COPD patients with true 24-hour symptoms control and full bronchodilatory effect from the first day of therapy".
The European filing comes after Almirall and partner Forest Laboratories submitted a New Drug Application to the US Food and Drug Administration at the end of last month.