European regulators have given the all clear to Almirall's Eklira Genuair to help alleviate the symptoms of chronic obstructive pulmonary disease (COPD), hot on the heels of a US green light.
The European Medicines Agency has approved Eklira Genuair (aclidinium) for use as a twice daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
The move was not unexpected as the Agency's advisory committee supported approving the drug, on the back of data showing the drug achieved significant bronchodilation on day one and after six months of treatment, and that the mean improvement in morning pre-dose (trough) FEV1 compared to placebo was 128 mL.
According to the Spanish drugmaker, Eklira Genuair provide "clinically meaningful improvements in lung function" over 12 hours following morning and evening administration, "which were evident within 30 minutes of the first dose".
In addition, the inhaler also offers clinically meaningful and statistically significant improvements in patient symptoms, including breathlessness and quality of life when compared to placebo, and patients treated with the drug required less rescue medication than patients treated with placebo, the firm said.
"The strength of the data supporting aclidinium’s role in improving health status, lung function and reducing exacerbations is a very welcome addition in the management of COPD and ultimately for people living with COPD,” said Professor Paul Jones, Professor of Respiratory Medicine and Head of the Division of Clinical Science at St George’s, University of London.
Earlier this week the US Food and Drug Administration approved the drug for sales in the country, where it is sold by Forest Laboratories and marketed as Tudorza Pressair.