FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Aradigm Receives CRL for Linhaliq, Citing Quality and Data Concerns

Feb. 2, 2018

The FDA issued a complete response letter to Aradigm over its Linhaliq (ciprofloxacin liposomal) submission for non-cystic fibrosis bronchiectasis, a severe, rare lung disease frequently associated with chronic lung infections, saying the drug could not be approved in its current form.

The agency recommended an independent third-party evaluation of the firm’s Phase III source data, as well as an additional Phase III clinical trial to demonstrate the inhalation formulation has a noteworthy effect on clinically significant endpoints and to “evaluate the co-primary endpoints of frequency and severity of exacerbations.”

Linhaliq, which the company submitted for review in July 2017, was called out by the agency over product quality and clinical data, with the agency calling for a new in vitro drug release method development report and additional product quality and microbiology information — as well as an additional human factors study demonstrating effective product packaging and instructions for use.

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