Previously known as Pulmaquin, Linhaliq is an investigational proprietary formulation of inhaled ciprofloxacin. The NDA is supported by positive results from the Phase 3 ORBIT-4 clinical trial (NCT02104245), along with data from the Phase 3 ORBIT-3 (NCT01515007) and the Phase 2b ORBIT-2 trials.
The trials showed that Linhaliq was capable of delaying a first pulmonary exacerbation and that the treatment significantly reduced the density of P. aeruginosa bacteria by the end of the first on-treatment period, or the first 28-day cycle. This anti-bacterial effect was maintained throughout the remaining cycles.
The studies also demonstrated that Linhaliq was safe and well tolerated by patients, with no changes in lung function or airway irritation reported, compared to the placebo group.
Acceptance of the NDA with priority review means the timing of the FDA assessment is accelerated compared to a standard review. As a result, the FDA’s goal date for completion of the review is Jan. 26, 2018.
“We are pleased with the FDA’s acceptance of our NDA filing with Priority Review,” Igor Gonda, Aradigm’s CEO, said in a press release. “We look forward to working with the FDA during the review process to support approval of Linhaliq and provide a much-needed treatment for NCFBE patients with chronic lung infection with P. aeruginosa.”
Additionally, Linhaliq received qualified infectious disease product (QIDP) designation for the treatment of NCFBE patients with chronic lung infections with P. aeruginosa, as well as fast-track status.
The FDA has also granted Linhaliq orphan drug status for liposomal ciprofloxacin for inhalation for the management of bronchiectasis, meaning Aradigm will receive certain incentives and assistance with Linhaliq’s regulatory development.
NCFBE is characterized by the abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, chronic lung infections, and bronchial wall damage.
Non-cystic fibrosis bronchiectasis patients with chronic P. aeruginosa-associated lung infections have a 6.5-times increased rate of hospitalization, three times higher mortality rate, and a worse quality of life compared to those who don’t have the bacteria-related infection.