FDA Advisory Group Sets Jan. 11 Review Date for Linhaliq, Potential Non-CF Bronchiectasis Therapy

FDA Advisory Group Sets Jan. 11 Review Date for Linhaliq, Potential Non-CF Bronchiectasis Therapy

A committee of the U.S. Food and Drug Administration (FDA) will meet next month to review an application for Linhaliq to be approved for the treatment of patients with non-cystic fibrosis bronchiectasis (NCFBE) who have chronic lung infections with Pseudomonas aeruginosa. The meeting is set for Jan. 11, 2018.

The FDA’s Antimicrobial Drugs Advisory Committee, which issues recommendations regarding approval to be considered by the FDA, will review Aradigm’s new drug application (NDA) for Linhaliq, the company announced in a press release 

Linhaliq, previously known as Pulmaquin, is a composition of encapsulated and free ciprofloxacin, a commonly prescribed antibiotic. Ciprofloxacin is used to treat many bacterial lung infections, including those caused by P. aeruginosa.

The NDA for Linhaliq was submitted in July 2017, after which the FDA assigned it priority review and set a goal of Jan. 26, 2018, for announcing its decision.

“FDA informed us, upon acceptance of our NDA, that they were planning an Advisory Committee for Linhaliq. At that time, we began preparing for this meeting together with a team of external key opinion leaders in the fields of chronic lung infections and U.S. drug regulations,” Igor Gonda, PhD, president and chief executive officer of Aradigm, said.

The NDA application was based on results from the Phase 3 ORBIT-4 (NCT02104245) and ORBIT-3 (NCT01515007) trials, and the Phase 2b ORBIT-2 trial. Additional preclinical and clinical data from Aradigm, as well as from other publicly available sources, are expected to further support the application.

The phase 3 trials were designed to evaluate the safety and effectiveness of once-daily inhaled Linhaliq in NCFBE patients with chronic P. aeruginosa infections, given in 28-day treatment cycles over the 48-week trials. Results from a combined analysis showed that Linhaliq significantly lowered the number of pulmonary exacerbations in treated patients compared to those given placebo. Furthermore, Linhaliq significantly decreased the density of P. aeruginosa bacteria by the end of the first 28-day treatment period.

“We welcome the opportunity to discuss publicly our Linhaliq clinical study results with the Advisory Committee in January. Our ultimate goal is to bring a much needed therapeutic treatment to NCFBE patients, a population with a high unmet medical need,” Gonda said.

NCFBE patients with chronic P. aeruginosa infections have a worse quality of life compared to patients without this bacterial infection, and a 6.5-fold higher increase in hospitalizations. There is currently no approved treatment for this condition.

Linhaliq was granted orphan drug designation for the management of bronchiectasis by the FDA, as well as Qualified Infectious Disease Product designation for the treatment of NCFBE patients with chronic lung infections caused by P. aeruginosa. Linhaliq also received FDA fast-track designation.

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