http://www.raredr.com/news/linhaliq-nda-acceptance
FDA Accepts New Drug Application for Treatment of Rare Lung Condition

Mathew Shanley and Jim Radke

This morning, Aradigm Corporation announced the U.S. Food and Drug Administration’s (FDA) acceptance of its Investigational New Drug Application (NDA) for Linhaliq for the treatment of patients with non-cystic fibrosis bronchiectasis (NCFBE) with chronic infections with Pseydomonas aeuruginosa (P. aeruginosa).

The specialty pharmaceutical company primarily focuses on the development of novel treatments for the prevention and treatment of life-threatening respiratory diseases. The application, which included data from a pair of Phase 3 clinical trials (ORBIT-4 and ORBIT-3) and a Phase 2b study (ORBIT-2), was submitted in late July.

Bronchiectasis widens and scars the airways in the lungs, and is frequently the result of infection. The alterations to the airway often lead to a buildup of mucus and, ultimately, more severe infections and permanent damage. Linhaliq, previously known as Pulmaquin, is a slow release formulation of ciprofloxacin, which is commonly used to fight bacteria.

“We are pleased with the FDA’s acceptance of our NDA filing with Priority Review,” said Dr. Igor Gonda, Chief Executive Officer, Aradigm Corporation 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.”

The Phase 3 ORBIT-4 study showed that non-cystic fibrosis bronchiectasis patients given Lunhaliq had a median time to first pulmonary exacerbations of 230 days versus 158 days in the placebo group (P = .0323). Further, there was a 37% reduction in the  pulmonary exacerbations frequency in the Linhaliq group compared to the placebo group (P = .0006) and a 60% reduction in  severe pulmonary exacerbations frequency in the Linhaliq group compared to placebo (P = .0031).

In the Phase 3 ORBIT-3 study, the median time to first pulmonary exacerbations was 214 days in the Linhaliq group vs 136 days in the placebo group; that difference was not statistically significant. Linhaliq was generally safe and well-tolerated in both Phase 3 studies and 89% of patients who completed ORBIT-3 and 91% of patients who completed ORBIT-4 enrolled in the studies’ open label extension studies.

At present, more than 150,000 people in the U.S. are affected by NCFBE, and patients who also have chronic infections with P.aeruginosa generally have higher mortality rates and a worse quality of life. There is currently no approved treatment for the condition.

Aradigm had already received Orphan Drug Designation for both Linhaliq and liposomal ciprofloxacin for the management of bronchiectasis, and the company was granted first Qualified Infectious Disease Product (QIDP) Designation and then Fast Tract Designation for the treatment of NCFBE patients with chronic lung infections with P. aeruginosa.

Aradigm’s inhaled ciprofloxacin formulations, including Linhaliq, are product candidates for the treatment of patients with cystic fibrosis and non-tuberculous mycobacteria (NTM), and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax.

The PDUFA (Prescription Drug User Fee Act) goal date for completion of FDA review of Aradigm’s Linhaliq NDA is January 26, 2018.
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