According to Almirall, it has submitted a marketing authorization application to the European Medicines Agency (EMA) for its aclidinium bromide DPI for the treatment of COPD. Aclidinium bromide is a long-acting inhaled muscarinic antagonist; the dry powder formulation is delivered by the Genuair inhaler.
Almirall and Forest Labs, which owns the US rights to the product, submitted an NDA to the US FDA in June 2011.
Eduardo Sanchiz, Almirall’s CEO commented: “Aclidinium bromide is the outcome of our strategic focus in the respiratory area and its regulatory submission, last month in US and now in Europe, is an important milestone for Almirall. Significant human and financial resources are being dedicated to research in this field, searching for innovative medicines to improve the treatment of patients suffering from respiratory diseases around the world.”
Read the Almirall press release.
