EC approves Eklira/Bretaris Genuair (Almirall/Menarini) for treatment of COPD

Almirall has announced that the European Commission has granted marketing approval to Eklira/Bretaris Genuair(aclidinium 322�g twice daily) in all EU member states, plus Iceland and Norway, as a maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD).

Clinical efficacy studies showed that aclidinium provides around the clock significant and sustained bronchodilation and symptoms control from the first dose. These benefits were evident within 30 minutes of the first dose. It also reduced moderate and severe exacerbations by approximately 30%. Patients treated with aclidinium needed less rescue medication than patients treated with placebo (p=0.005). It also improved COPD symptoms such as dyspnoea, cough and sputum production.

The FDA has on 23 July 2012 approved aclidinium bromide as Tudorza Pressair for Forest Pharmaceuticals for COPD. Menarini will have joint commercialisation rights across the majority of EU member states (excluding the UK, the Netherlands and the Nordic countries where Almirall retains sole marketing rights for the product)as well as Russia, Turkey and other CIS countries under the brand name Bretaris Genuair, whilst Almirall will market the product in Europe as Eklira Genuair.