Aradigm Corporation, which submitted an MAA for its dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients in March 2018, has announced that it submitted responses to EMA Day 120 questions on January 23, 2019. The company said that it anticipates receiving a Day 180 list of outstanding issues toward the end of March.
In the US, the company had submitted an NDA for the dual release inhaled ciprofloxacin — then called Linhaliq, now called Apulmiq — in July 2017. In January 2018, the FDA issued a complete response letter to the NDA and recommended independent verification of some Phase 3 trial results.
In December 2018, Aradigm announced that it had scheduled a meeting with the FDA to discuss the results of a third-party evaluation of data from the ORBIT-3 and ORBIT-4 trials which were used to support the application. The company says now that it expects formal minutes from that meeting, which took place on January 25, 2019, to be available within a month.
Read the Aradigm press release.
