Aradigm Corporation has received a complete response letter from the FDA in response to its NDA for Linhaliq dual release inhaled ciprofloxacinfor the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the company said. An FDA advisory committee recently voted against recommending approval of the application.
According to Aradigm, the letter cited concerns with clinical data, human factors validation study and product quality and recommended an additional Phase 3 trial and independent verification of previous Phase 3 results. Other recommendations included an additional human factors study, a new in vitro drug release method report, and information regarding product quality.
Data from two Phase 3 studies, ORBIT-3 and ORBIT-4, were used to support the application. The NDA was submitted in July 2017.
Aradigm President and CEO Igor Gonda commented, “We remain confident in the efficacy, safety and quality of Linhaliq and will request a meeting with FDA to discuss the topics covered in the CRL with the view to developing plans to move towards resubmission of the Linhaliq NDA as soon as possible. We are committed to continue working on the approval of Linhaliq for NCFBE patients who have very severe disease with high morbidity and mortality and no available treatment options. We thank these patients and their care givers for participating in a decade of clinical research that brought us to this point. Our focus is also on the submission in the near future for marketing approval in the European Union.”
Read the Aradigm press release.
