Almirall ‘to file Eklira application with EMEA’

Almirall has announced that it intends to file an application with the European Medicines Agency (EMEA) in early 2010 for the approval of its once-daily long-acting muscarinic antagonist Eklira (aclidinium bromide).

The treatment is a maintenance bronchodilator treatment and means of symptom control for those suffering from chronic obstructive pulmonary disease (COPD).

According to the firm, the filing of the application next year will be accompanied by a clinical programme, two 12-month studies and an exercise endurance and lung hyperinflation trial.

A rate of onset study will also be conducted, it added.

Professor Leonardo Fabbri, a member of the Scientific Committee of the Global Initiative for Chronic Obstructive Lung Disease, said that around 80 million people suffer from COPD.

“We are encouraged to see new developments for the treatment of this disease […] which may provide physicians with new options for reducing symptoms and improving quality of life of their patients,” he added.

In July, Almirall revealed that it had experienced a financially strong half-year, as its net income for the period totalled 103.4 million euros (88.31 million pounds).