Almirall To File MAA With European Medicines Agency For Eklira

Almirall has reported its intention to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMEA) for muscarinic antagonist Eklira (aclidinium bromide) in early 2010, for the maintenance bronchodilator treatment and symptom control of COPD.

Reportedly, the filing for once-daily aclidinium bromide 200µg will be supported by a large clinical programme, including two 12-month studies (ACCLAIM/COPD I and II), an exercise endurance and lung hyperinflation study and a rate of onset study.

In the ACCLAIM/COPD phase III studies, aclidinium produced a consistent and sustained statistically significant difference compared to placebo in trough FEV1, throughout the 12-month treatment period.

In the studies Aclidinium has significantly increased the percentage of patients showing a clinically relevant improvement in health-related quality of life compared to placebo. Also, aclidinium significantly delayed the time to the first moderate to severe exacerbation in ACCLAIM/COPD II.

Additionally, safety and tolerability of aclidinium bromide assessed in approximately 2500 subjects, including 1647 patients treated for 1 year, were similar to placebo.

The positive results of two further clinical studies showed that a single dose of aclidinium had a bronchodilation effect comparable to the currently marketed long acting antimuscarinic antagonists, and is clinically relevant improvement in exercise endurance time of moderate to severe COPD patients.

Per-Olof Andersson, executive director of R&D at Almirall, said: “Eklira (aclidinium bromide) appears to demonstrate nearly full activity from the initial dose, with a low potential for traditional anticholinergic side effects. Combined with the advantage of our new multidose inhaler Genuair, we believe that we have an exciting new treatment option for COPD patients”