A committee of the U.S. Food and Drug Administration (FDA) will review an application requesting that Linhaliq be approved to treat non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections due to Pseudomonas aeruginosa next month.
The review by the Antimicrobial Drugs Advisory Committee, which issues recommendations regarding approval to be considered by the FDA, is set for Jan. 11, Aradigm, the therapy’s developer, announced in a press release. A new drug application for Linhaliq was accepted by the FDA and assigned priority review in September, with a goal of announcing a decision by Jan. 26, 2018.
“We welcome the opportunity to discuss publicly our Linhaliq clinical study results with the Advisory Committee in January,” Igor Gonda, president and CEO of Aradigm, said in the release. “Our ultimate goal is to bring a much needed therapeutic treatment to NCFBE patients, a population with a high unmet medical need,” Gonda added.
Linhaliq, formerly known as Pulmaquin, is a new formulation composed of encapsulated and free forms of ciprofloxacin, a widely used antibiotic. Ciprofloxacin is often used to treat acute pulmonary infections caused by bacteria, including P. aeruginosa.
The NDA was based on data from the Phase 3 ORBIT-4 clinical trial (NCT02104245) and 3 ORBIT-3 (NCT01515007) study, plus results of a Phase 2 trial. Additional preclinical and clinical data from Aradigm, as well as from other publicly available sources, are expected to further support the application.
Combined analysis of Phase 3 trial data, involving 582 patients with NCFBE treated in 28-day cycles, found that once-daily cyclical treatment over 48 weeks significantly delayed a first pulmonary exacerbation compared to placebo. Specifically, time to a first moderate or severe flare was 302 days in treated patients compared to 198 days in those given a placebo. Moderate or severe flares were defined as those requiring either antibiotic treatments or hospitalization.
In addition, the treatment was seen to significantly reduce P. aeruginosa bacteria load compared to placebo at the end of the first treatment period, a benefit that was sustained through subsequent treatment cycles in the trials.
Linhaliq was also found to be safe and well-tolerated, with no differences in changes in lung function or airway irritation reported between treated and placebo patients.
The FDA previously designated Linhaliq an orphan drug for the management of bronchiectasis, and Qualified Infectious Disease Product (QIDP) as a potential treatment of NCFBE patients with chronic P. aeruginosa pulmonary infections.
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