Aradigm Corporation has submitted a marketing authorization request to the European Medicines Agency (EMA) for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients who with a chronic Pseudomonas aeruginosa bacterial lung infection.
The agency has 21 days to decide if the application is complete, after which it will start the review process, according to a company press release. At the moment there are no approved treatments for NCFBE to prevent or reduce the burden of bronchiectasis driven by lung infections.
Linhaliq, previously known as Pulmaquin, is a liquid mixture of liposomes and the antibiotic ciprofloxacin, which can counter several bacteria, including P. aeruginosa. Results from two Phase 3 trials supported Aradigm’s marketing authorization application. They evaluated the safety and effectiveness of Linhaliq delivered as a once-a-day inhaled formulation in patients with NCFBE with chronic P. aeruginosa lung infections.