Aradigm Corporation, which recently announced that it has filed for bankruptcy, said that it held a Type B meeting with the FDA on January 25, 2019 at which the agency expressed continued concerns about data from the ORBIT-3 and ORBIT-4 trials of Apulmiq inhaled dual release ciprofloxacin for the treatment of P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients.
The FDA issued a complete response letter to Aradigm’s NDA for Apulmiq (then called Linhaliq) for that indication in January 2018. In December 2018, when the company announced that it had scheduled the meeting with the agency, Aradigm said that it believed that a third party evaluation had confirmed the analyses of results from the studies that were included in the NDA.
According to Aradigm, “The Agency stated that based on the TPE information presented by Aradigm it appears the TPE findings are consistent with the original Phase 3 trial results. However, they continue to have concerns over the discordance in the results of the pre-specified primary and secondary endpoints between the ORBIT-3 and ORBIT-4 trials.”
The company said that it asked to resubmit the NDA specifically for approval of Apulmiq for the treatment of NCFBE patients with P. aeruginosa infections and frequent exacerbations associated with a phenotype that it says is rare. The two Phase 3 studies showed consistent benefits for this group of patients, the company noted.
Aradigm said that the FDA “recommended that Aradigm conduct an additional adequate and well-controlled trial to demonstrate a significant treatment effect of Apulmiq on a clinically meaningful endpoint” and “acknowledged that appropriate endpoints for clinical trials have evolved over time, and, therefore, frequency of exacerbation as the primary endpoint in a future clinical trial is reasonable.”
The CRL had recommended a new in vitro drug release method report, a new human factors study, and information regarding product quality. Aradigm says that the method development report has been submitted, and the human factors study and the remedial work on product quality are almost complete.
Read the Aradigm press release.
