Aradigm Corporation has announced that the EMA will review an Aradigm MAA for Pulmaquin inhaled liposomal ciprofloxacin under the centralized authorization procedure. According to the company, “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.”
Enrollment in the ORBIT-3 and ORBIT-4 Phase 3 pivotal trials of Pulmaquin for the treatment of non-CF BE was completed in the fall of 2015. Grifols acquired an exclusive license for Pulmaquin in 2013, agreeing to pay up to $65 million in Phase 3 development expenses. and in its 2015 financial results announcement, Aradigm said that it has utilized the entire $65 million.
Aradigm Chief Medical Officer Juergen Froehlich commented, “We are pleased that the EMA has agreed to review Pulmaquin through the centralized review process. 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.”
Read the Aradigm press release on the Pulmaquin review.
Read the Aradigm press release on its 2015 financial results.
