26 September 2017 - - Hayward, California-based respiratory disease therapeutics developer Aradigm Corp. (NASDAQ: ARDM) has been granted filing with priority review by the The US Food and Drug Administration for its new drug application (NDA) for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) in patients with chronic infections with Pseudomonas aeruginosa (P. aeruginosa), the company said.
Linhaliq is an investigational proprietary formulation of ciprofloxacin for inhalation.
The granting of priority review accelerates the timing of the FDA review of the application compared to a standard review. The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Linhaliq NDA is January 26, 2018.
Non-cystic fibrosis bronchiectasis (NCFBE) is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections.
NCFBE patients who have chronic infections with P. aeruginosa have a 6.5-fold increase in hospitalisation, three times higher mortality, and a worse quality of life compared with those without P. aeruginosa infections.
There is currently no drug approved for the treatment of this condition.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases.
The company'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.