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Aradigm Announces Decision for Centralized Review of Pulmaquin by the European Medicines Agency
Aradigm Corporation (Nasdaq:ARDM) (the "Company") today announced that the European Medicines Agency (EMA) has approved its request to review Pulmaquin®, Aradigm’s investigational inhaled liposomal ciprofloxacin product, under the Centralised Authorisation Procedure drug review process. This procedure results in a single marketing authorization that is valid in all 28 European Union countries, as well as three European Economic Area countries. Aradigm requested, and was granted, the centralized pathway on the basis that Pulmaquin represents a significant technical innovation for the potential treatment of non-cystic fibrosis bronchiectasis (non-CF BE) associated with chronic Pseudomonas aeruginosa (P. aeruginosa) infection.
“We are pleased that the EMA has agreed to review Pulmaquin through the centralized review process,” said Dr. Juergen Froehlich, Aradigm’s Chief Medical Officer. “This will enable us to streamline the process of gaining a license in all member states of Europe, with the opportunity of providing those living with non-CF BE and chronic lung infections with P. aeruginosa quicker access to Pulmaquin. Registration through the Centralized Procedure is typically reserved for products with significant therapeutic, scientific or technical innovation. This favorable decision reflects positively on the innovative approach we are taking investigating Pulmaquin for the treatment of this current unmet medical need in non-CF BE patients.”
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