Aradigm Corporation says that it has scheduled a meeting with the FDA to discuss results from the Phase 3 ORBIT-3 and ORBIT-4 trials of Apulmiq (formerly Linhaliq) dual release inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients now that a third party evaluation of the results has been completed.
In January 2018, the FDA issued a complete response letter to the company’s NDA for Linhaliq that questioned the clinical data. Aradigm says that in response to the discovery of errors in the analysis of pulmonary exacerbation data conducted by a CRO, the company had conducted a manual re-review of the data. The CRL noted concerns related to that manual re-review and said that the agency required third party verification before it could complete its review.
According to the announcement, “Aradigm believes that the results of the TPE verify the significant treatment effects of Apulmiq in ORBIT-4 for the primary endpoint of prolongation of the time to first PE and the secondary endpoints of frequency for all PEs and for severe PEs, as previously reported in the NDA submitted on 26 July 2017. The TPE results also verify the already reported non-significant primary and secondary PE endpoint results of ORBIT-3.”
Aradigm also said that the FDA conducted an inspection of the company in January 2018 that was related to the manual re-review, the re-adjudication process, and the overall conduct of the Phase 3 studies. The FDA’s Division of Clinical Compliance Evaluation issued a letter on November 27, 2018 regarding the results of the audit, which “concluded that there were no objectionable conditions or practices identified that would justify enforcement action,” the company said.
The announcement concluded, “Aradigm remains confident in the efficacy, safety and quality of Apulmiq. We are committed to continue working toward the approval of Apulmiq for NCFBE patients who have chronic infection with P. aeruginosa, resulting in severe disease with frequent PEs, high morbidity and mortality, and no available treatment options.”
Read the Aradigm press release.
