Posted by Michael Wonder on 28 Jul 2017
Aradigm submits new drug application to FDA for U.S. marketing approval of Linhaliq in non-cystic fibrosis bronchiectasis
27 July 2017 - Aradigm Corporation today announced it has submitted its new drug application to the U.S. FDA for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.
Aradigm is submitting the Linhaliq NDA based on the positive Phase 3 pivotal clinical trial ARD-3150-1202 (ORBIT-4) and confirmatory 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 other information about ciprofloxacin from publicly available sources.
Aradigm received orphan drug designation for liposomal ciprofloxacin for inhalation for the management of bronchiectasis and of Linhaliq for the management of bronchiectasis. Additionally, for Linhaliq, Aradigm was granted qualified infectious disease product Designation for the treatment of NCFBE patients with chronic lung infections with P. aeruginosa followed by fast track designation.
