Almirall files for EU approval of new COPD therapy

Almirall has applied for European regulatory approval of a fixed combination of aclidinium bromide and formoterol fumarate, for the treatment of chronic obstructive pulmonary disease (COPD).

The marketing authorisation application to the European Medicines Agency is supported by efficacy and safety data from two pivotal phase III trials, which were conducted in 25 countries worldwide.

Almirall's co-primary endpoints in the studies were successfully met, with the combination therapy showing statistically significant lung function improvement compared with each individual component.

The investigational treatment combines two already approved and marketed bronchodilators, which are delivered twice-daily via the Genuair inhaler device.

Dr Bertil Lindmark, chief scientific officer at Almirall, said: "We have reached another important strategic milestone in the development of innovative treatments geared towards improving the quality of life in patients with COPD."

Last month, the company reported new clinical data on its drug Sativex, demonstrating its efficacy and safety in the prevention of multiple sclerosis spasticity.