NDA Submitted for Non-Cystic Fibrosis Bronchiectasis Treatment

Linhaliq is a novel Tx for non-cystic fibrosis bronchiectasis in patients with chronic lung infections with <i>P. aeruginosa</i>
Linhaliq is a novel Tx for non-cystic fibrosis bronchiectasis in patients with chronic lung infections with P. aeruginosa

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). 

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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.

For more information visit Aradigm.com.