The pharmaceutical company Aradigm has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Linhaliq (ciprofloxacin) as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) in patients with chronic lung infections with Pseudomonas aeruginosa, according to a press release.
The NDA is supported by positive results from the Phase 3 ORBIT-4 pivotal clinical trial (NCT02104245) and data from the Phase 3 ORBIT-3 (NCT01515007) and the Phase 2b ORBIT-2 trials. Additional preclinical and clinical data from Aradigm and other publicly available sources are expected to provide additional supporting evidence for Linhaliq’s NDA designation.
Previously known as Pulmaquin, Linhaliq is composed of a mixture of encapsulated and free forms of the widely used antibiotic ciprofloxacin. This antibiotic is often used to treat acute lung infections caused by bacteria, including P. aeruginosa.
Phase 3 clinical trials included a total of 582 patients with NCFBE who received once-daily Linhaliq or a placebo in six cycles of 28 days of treatment plus 28 days off treatment. This regimen was followed by a 28-day, open-label extension in which all patients received Linhaliq.
Overall, the investigative treatment was shown to increase the time for a first pulmonary exacerbation in NCFBE patients compared with the placebo-treated group. In addition, Linhaliq significantly reduced the density of P. aeruginosa bacteria by the end of the first treatment period (the first 28 days). This effect was found to be consistent throughout all of the remaining treatment cycles.
The results of the Phase 3 trials also demonstrated that Linhaliq was generally safe and well-tolerated by patients. The treatment did not induce significant changes in patients’ lung function or airway irritation compared with a placebo. The rates of treatment-related adverse events were similar in Linhaliq and placebo-treated patients.
The FDA granted Linhaliq orphan drug designation for the management of bronchiectasis and qualified infectious disease product (QIDP) designation for the treatment of NCFBE patients with chronic P. aeruginosa lung infections. The FDA also granted fast track designation to Linhaliq.
Aradigm also will submit a marketing authorization application to the European Union for Linhaliq as a treatment for patients with NCFBE who have chronic P. aeruginosa lung infections.