Shares of Aradigm (NASDAQ: ARDM) are up 26% after the company this morning said its New Drug Application (NDA) for Linhaliq™ for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic infections with Pseudomonas aeruginosa (P. aeruginosa) has been accepted for filing with Priority Review by the U.S. Food and Drug Administration (FDA). Priority Review advances the FDA review of the application more quickly than a standard review. The company’s PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review is January 26, 2018. “We look forward to working with the FDA during the review process to support approval of Linhaliq and provide a much needed treatment for NCFBE patients with chronic lung infection with P. aeruginosa,” Aradigm chief executive officer Dr. Igor Gonda stated in the news release.
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About Aradigm
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. Aradigm has completed two phase 3 clinical trials with Linhaliq, an investigational proprietary formulation of ciprofloxacin for inhalation, for the treatment of NCFBE and submitted a New Drug Application to the FDA for this indication. Aradigm’s inhaled ciprofloxacin formulations, including Linhaliq, are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria (NTM), and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax. For more information, visit www.aradigm.com.
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