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.
Linhaliq, formerly known as Pulmaquin, is composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin.
The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
In addition, Aradigm intends to submit Linhaliq for marketing authorization in the European Union for the treatment of patients with NCFBE who have chronic lung infections with P. aeruginosa.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. It has completed Phase 3 development of Linhaliq (an investigational proprietary formulation of ciprofloxacin for inhalation) for the treatment of NCFBE.
Aradigm's inhaled ciprofloxacin formulations including Linhaliq are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax.
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