Aradigm Corporation (NASDAQ:ARDM) reported that the Antimicrobial Drugs Advisory Committee of the US FDA did not recommend permission for Linhaliq™ as a cure for NCFBE people suffering with chronic lung Pseudomonas aeruginosa problems.
The Advisory Committee chose 12 “no” to 3 “yes”, while there existed one abstention, on the question that asked has the applicant offered considerable evidence of the efficacy and safety of ciprofloxacin dispersion for inhalation in deferring the time to initial exacerbation after commencing treatment in people with non-cystic fibrosis bronchiectasis and chronic lung problems with Pseudomonas aeruginosa. The U.S. FDA is not destined by the Advisory Committee’s result, but takes its information into consideration when assessing investigational drugs.
Igor Gonda, Ph.D., the CEO and President of Aradigm, expressed that while they are disappointed with the results of the ADAC vote, they remain assured in the efficacy, tolerability and safety of Linhaliq in NCFBE patients. They will work with the FDA to resolve the concerns discussed by the panel as they close their review of Linhaliq. They are committed to assisting NCFBE patients, who as of now have no accessible treatment options.
The FDA has established a PDUFA action date of next year on January 26, for the closure of its assessment of Linhaliq. The clinical plan for Linhaliq was advanced with projection from the FDA, who even allowed Orphan Drug in June 2011, Qualified Infections Disease Product in June 2014, and Fast Track in August 2014 designations to Linhaliq.
The Linhaliq filing was based on report from three clinical trials. Two Phase 3 trials, ORBIT-4 and ORBIT-3, were identically intended, multinational, randomized, placebo controlled and double-blind studies. Both were performed concurrently in alike geographies over 48 weeks, with another four weeks of open-label therapy and a thirty-day safety follow up.
In the last trading session, the stock price of Aradigm declined more than 33% to close the day at $2.26.