Aradigm Corporation has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Linhaliq, a novel treatment of non-cystic fibrosis bronchiectasis (NCFBE) in patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa).
Linhaliq (previously known as ‘Pulmaquin’) consists of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. Linhaliq has previously been granted Orphan Drug status for the management of bronchiectasis.
The NDA is based on results from two Phase 3 clinical trials, ARD-3150-1202 (ORBIT-4) and ARD-3150-1201 (ORBIT-3). A total of 582 patients with NCFBE took part in both 48-week, double blind trials. Results showed that the median time to first pulmonary exacerbation (PE) in ORBIT-4 was 230 days for the Linhaliq group compared to 158 for the placebo group (P=0.0323). However the median time to first PE in ORBIT-3 was deemed not statistically significant; 214 and 136 for Linhaliq and placebo groups, respectively (P=0.9743).
Both studies demonstrated a statistically significant reduction in P. aeruginosa density at Day 28, the end of the first on-treatment period (ORBIT-3: P=<0.0001; ORBIT-4: P=<0.0001). The percentage of patients who decided to extend treatment with Linhaliq was 89% and 91% for ORBIT-3 and ORBIT-4, respectively.
There are currently no treatments approved for NCFBE patients to prevent and reduce the number of pulmonary exacerbations.
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