Aradigm Corporation announced it has submitted its Marketing Authorisation Application (MAA) to European Medicines Agency (EMA) for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infection with Pseudomonas aeruginosa (P. aeruginosa). The company is submitting a mixed MAA for Linhaliq that is based on the positive Phase 3 pivotal clinical trial ARD-3150-1202 (ORBIT-4) and supporting evidence from Phase 3 study ARD-3150-1201 (ORBIT-3) and Phase 2b study ARD-3150-0902 (ORBIT-2), together with other supporting evidence from proprietary preclinical and clinical studies, as well as referencing additional information about ciprofloxacin from publicly available sources. The EMA has a 21-day validation review period to determine whether the MAA is complete before starting the procedure. Linhaliq, formerly known as Pulmaquin®, is composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. Ciprofloxacin, available in oral and intravenous formulations, is a widely prescribed antibiotic. It is used often to treat acute lung infections because of its broad-spectrum antibacterial activity against various bacteria, such as P. aeruginosa. There are currently no treatments approved for NCFBE patients to prevent and reduce the number of pulmonary exacerbations (PEs). The Phase 3 clinical program for Linhaliq in NCFBE consisted of two worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that were identical in design except for a pharmacokinetics sub-study that was conducted in one of the trials. Each trial enrolled NCFBE patients (278 in ORBIT-3 and 304 in ORBIT-4) into a 48-week double-blind period consisting of 6 cycles of 28 days on treatment with Linhaliq or placebo plus 28 days off treatment, followed by a 28 day open label extension in which all participants received Linhaliq (total treatment duration, including the double-blind period, of approximately one year). The superiority of Linhaliq vs. placebo during the double-blind period was evaluated in terms of the primary endpoint - time to first PE, while key secondary endpoints included the reduction in the number of PEs, the number of PEs requiring the administration of antibiotics, the number of severe PEs, as well as improvements in quality of life measures. Lung function was monitored as a safety indicator.