US FDA serves Aradigm CRL, Phase III data wanted
Concern areas outlined in the US Food and Drug Administration’s (FDA’s) complete response letter (CRL) include clinical data, human factors validation, and product quality.
Linhaliq is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with pseudomonas aeruginosa.
In the CRL, the Administration recommended an independent third party check over Phase III study results, and conduct “an additional Phase III clinical trial that demonstrates a significant treatment effect on clinically meaningful endpoints” to test the drug’s efficacy over a period of two years, said Aradigm.
A Human Factors Study to test the effectiveness of product packaging and instructions was also requested, as well as a new in vitro drug release method development report.
“We remain confident in the efficacy, safety and quality of Linhaliq and will request a meeting with the 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,” said CEO Igor Gonda.
“Our focus is also on the submission in the near future for marketing approval in the European Union,” he added.
The rejection follows Aradigm’s announcement on January 11, which stated the FDA’s antimicrobial drugs advisory committee (ADAC) had not recommended approval of Linhaliq
