FDA Advisory Committee Does Not Recommend Approval of Inhalant Linhaliq

FDA Advisory Committee Does Not Recommend Approval of Inhalant Linhaliq

The Antimicrobial Drugs Advisory Committee (ADAC) of the U.S. Food and Drug Administration (FDA) did not recommend approval of Aradigm’s Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung Pseudomonas aeruginosa infections.

NCFBE patients with chronic P. aeruginosa infections have a 6.5-fold increase in hospitalizations, and three times higher mortality than patients without the infection. There is no current approved treatment for this condition.

Linhaliq, previously known as Pulmaquin, is an inhaled formulation of ciprofloxacin, a common antibiotic that is used to treat bacterial lung infections, including those caused by P. aeruginosa.

The ADAC met on Jan. 11 to review an application for the approval of Linhaliq. The committee, composed of 16 voting members, was asked 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?

Twelve members of the committee voted “no,” three voted “yes,” and one member abstained.

While the FDA does not have to adhere to the recommendation of the ADAC, it does take the advice into consideration upon review of the drug application for approval.

Despite the recommendation of the ADAC not to approve Linhaliq, Igor Gonda, PhD, president and CEO at Aradigm said in a press release, “we remain confident in the efficacy, safety and tolerability of Linhaliq in NCFBE patients.”

Gonda added that, “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.”

The application for the approval of Linhaliq was based on results from the Phase 3 ORBIT-4 (NCT02104245) and ORBIT-3 (NCT01515007) trials, and the Phase 2b ORBIT-2 trial. These trials provided evidence that supported the use of Linhaliq in patients with NCFBE with chronic lung infections with P. aeruginosa.

The trials showed that the use of Linhaliq significantly decreased the number of pulmonary exacerbations in treated patients compared to those given placebo, as well as decreasing the density of the bacteria by the end of a 28-day treatment period.

The Prescription Drug User Fee Act (PDUFA) date for Linhaliq is Jan. 26, which is the deadline for the FDA to complete its review. Linhaliq was previously granted orphan drug designation in June 2011, a qualified infectious disease product designation in June 2014, and fast track status in August 2014.


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