29 January 2018 - Aradigm today announces that it received a complete response letter from the US FDA regarding its new drug application for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa).

The Linhaliq application was based on data from three clinical studies. Two Phase 3 studies, ORBIT-3 and ORBIT-4, were identically designed, multinational, randomised (2:1), double-blind and placebo controlled. Both were conducted concurrently in similar geographies over 48 weeks, with an additional 4 weeks of open-label treatment and a 30-day safety follow up. Together with the Phase 2b ORBIT-2 study, these trials were part of the submission to provide evidence of the clinical benefit of Linhaliq for patients with NCFBE who have chronic lung infections with P. aeruginosa.

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