Aradigm announces results of third party evaluation of Phase III clinical trials for Apulmiq (formerly Linhaliq) to treat bronchiectasis .
Aradigm Corporation announced results of a third party evaluation (TPE) of the Phase III clinical trial results for Apulmiq ( formerly Linhaliq). Aradigm received a Complete Response Letter (CRL) on 26 January 2018, from the FDA regarding its New Drug Application (NDA) for Apulmiq as a treatment for non-cystic fibrosis bronchiectasis patients with chronic lung infection with Pseudomonas aeruginosa (P. aeruginosa).
The CRL identified issues related to a manual re-review of patient-level pulmonary exacerbation (PE) data conducted by Aradigm after errors were discovered in the analyses performed by a contract research organization. The CRL stated that an independent third party would need to verify the results of the ORBIT-3 and ORBIT-4 Phase III trials before the FDA could draw any conclusions regarding the safety and efficacy of Apulmiq from these trials.
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. These endpoints were all specified in the original statistical analysis plan (SAP) which was reviewed and agreed by FDA.
In addition, Aradigm recently received a letter from the FDA Division of Clinical Compliance Evaluation on 27 November 2018 regarding the outcome of an FDA Inspection of Aradigm in January 2018 to audit the conduct of the Phase III trials, the unplanned manual re-review of patient-level PE data and the re-adjudication process by Aradigm. The letter concluded that there were no objectionable conditions or practices identified that would justify enforcement action, and no Form 483 was issued.
A meeting has been scheduled with the FDA to discuss these Phase III trial results now that the TPE has been conducted. .
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