Aradigm sought CRL from FDA pertaining to NDA for Linhaliq treating NCFBE patients

Aradigm Corporation asserted that it received a Complete Response Letter from the US Food and Drug Administration regarding its New Drug Application (NDA) for Linhaliq for treating non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa. The CRL states that the FDA has determined that it cannot approve the NDA in its present form and provides specific reasons for this action along with recommendations needed for re-submission; the areas of concern include clinical data, human factors validation study and product quality.

The Linhaliq application was based on data from three clinical studies. Two Phase 3 studies, ORBIT-3 and ORBIT-4, were identically designed, multinational, randomized (2:1), double-blind and placebo controlled.

Igor Gonda, Ph.D., president and chief executive officer at Aradigm said “We remain confident in the efficacy, safety and quality of Linhaliq and will request a meeting with FDA to discuss the topics covered in the CRL with the view to developing plans to move towards resubmission of the Linhaliq NDA as soon as possible. We are committed to continue working on the approval of Linhaliq for NCFBE patients who have very severe disease with high morbidity and mortality and no available treatment options. We thank these patients and their care givers for participating in a decade of clinical research that brought us to this point.”

Corrections in the CRL enumerate verification of the Phase 3 results via analyses of source data as per the statistical analysis plan and an additional Phase 3 clinical trial that demonstrates a significant treatment effect on clinically meaningful endpoints which could evaluate the co-primary endpoints of frequency evaluating durable evidence of efficacy over a period of two years.

Image Source: Aradigm