Aradigm Corporation said that the FDA’s Antimicrobial Drugs Advisory Committee (ADAC) has voted against approval of the company’s NDA for Linhaliq dual release inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients.
The company submitted the NDA in July 2017, and the FDA granted the application priority review, with a PDUFA date of January 26, 2018.
In response to the question: “Has the applicant provided substantial evidence of the safety and efficacy of ciprofloxacin dispersion for inhalation in delaying the time to first exacerbation after starting treatment in non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa?” the committee voted 12 “no” and 3 “yes”, with 1 committee member abstaining.
Aradigm President and CEO Igor Gonda said, “While we are disappointed with the outcome of the ADAC vote, we remain confident in the efficacy, safety and tolerability of Linhaliq in NCFBE patients. We will work closely with the FDA to address the issues discussed by the panel today as they complete their review of Linhaliq. We are committed to helping NCFBE patients, who presently have no available treatment options.”
Read the Aradigm press release.
