Aradigm has submitted a marketing authorization application to the EMA for Linhaliq dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the company said. In January 2018, the FDA issued a CRL for Aradigm’s NDA for Linhaliq.
According to Aradigm, the MAA is supported by data from the Phase 3 ORBIT-3 and ORBIT-4 studies, as well as data from other preclinical and clinical trials.
The company said that it held pre-submission meetings with the EMA in late 2017 and that “Based on these discussions, the statistical analysis of the results was changed from the pre-specified plan to stratification based on sex and the frequency of pulmonary exacerbations in the prior year, as the stratum for current smokers contained a small number of subjects.”
Using the new analyses, ORBIT-4 demonstrated a statistically significant increase in days to first pulmonary exacerbation for patients treated with Linhaliq compared to placebo and a statistically significant decrease in the frequency of exacerbations over the treatment period, the frequency of exacerbations requiring antibiotics, and the frequency of severe exacerbations for Linhaliq compared to placebo.
Both ORBIT-3 and ORBIT-4 demonstrated a statistically significant reduction in the density of P. aeruginosa at the end of the first 28-day treatment period. Neither ORBIT-3 nor ORBIT-4 showed a statistically significant improvement in quality of life.
Read the Aradigm press release.
