It’s official: Aradigm Corporation’s meeting with the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is slated for January 11, 2018.
The congregation is being held for the review of Linhaliq, a potential therapy for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa
. In July, Aradigm submitted the New Drug Application (NDA)
for Linhaliq, and the FDA responded in September
by setting a Prescription Drug User Fee Act (PDUFA) goal date of January 26, 2018 for the completion of its review.
Linhaliq, previously known as Pulmaquin, is an inhalation formulation of unencapsulated ciprofloxacin, with a slow-release formulation of liposomal dissolved in an aqueous solution. The acceptance of the application was the result of data from a Phase 2b study (ORBIT-2) and a pair of Phase 3 clinical trials (ORBIT-3, ORBIT-4).
Infections are typically the cause of bronchiectasis, which is characterized by a widening and scarring of the airways in the lungs. The alterations to the airways can result in mucus buildups which, in turn, lead to recurrent infections and an increase in inflammation. The condition can cause permanent bronchial wall damage, and is estimated to affect 150,000 Americans. At present, there are no approved therapies.
“FDA informed us, upon acceptance of our NDA, that they were planning an Advisory Committee for Linhaliq,” said Igor Gonda, Ph.D., President and Chief Executive Officer at Aradigm in a press release
. “At that time, we began preparing for this meeting together with a team of external key opinion leaders in the fields of chronic lung infections and U.S. drug regulations. We welcome the opportunity to discuss publicly our Linhaliq clinical study results with the Advisory Committee in January. Our ultimate goal is to bring a much-needed therapeutic treatment to NCFBE patients, a population with a high unmet medical need.”
The Phase 3 ORBIT-4 study concluded that non-cystic fibrosis bronchiectasis patients administered Lunhaliq had a median time to first pulmonary exacerbations of 230 days compared to 158 days in the placebo group (P
=.0323). The drug was generally safe and well-tolerated in both Phase 3 studies.
For more information from the FDA, including application, designations and approvals, follow Rare Disease Report