FDA advisory committee schedules review of Linhaliq NDA

Aradigm has announced that the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) will meet on January 11, 2018 to review the NDA for Linhaliq inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients. Linhaliq is a mix of liposome-encapsulated and unencapsulated ciprofloxacin.

The company submitted the NDA for Linhaliq, formerly known as Pulmoquin, in July 2017, and the FDA granted the application priority review status, with a PDUFA date of January 26, 2018.

Results from both the ORBIT-3 and ORBIT-4 trials, which were released in December 2016, demonstrated an increase in median time to the first pulmonary exacerbation for patients using Pulmaquin compared to placebo; however, the increase, while similar in both studies, was statistically significant only for ORBIT-4.

Aradigm CEO Igor Gonda commented, “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 US drug regulations. 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.”

Read the Aradigm press release.