CHMP recommends EU approval of Eklira (Almirall) for COPD

The EMA's CHMP has issued a positive opinion for the regulatory approval of Eklira (aclidinium), from Almirall, in all EU member states as a maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). As part of its assessment, CHMP reviewed efficacy and safety data of aclidinium BID from more than 2,500 patients. The clinical program included 26 clinical studies conducted in 26 countries worldwide. The CHMP also assessed the Genuair Inhaler, the Almirall's proprietary multidose dry powder inhaler. Almirall recently signed a license agreement granting Menarini joint commercialisation rights across the majority of EU member states as well as Russia, Turkey and other CIS countries; this deal excludes the UK, the Netherlands and the Nordic countries. Menarini will market the product under the trade name Bretaris Genuair. Aclidinium is also undergoing regulatory assessment in the US by the FDA and approval is expected in 2012.