Aradigm announces FDA advisory committee meeting for Linhaliq on January 11
Aradigm Corporation announced that a meeting of the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration has been scheduled for January 11, 2018 to review the company's New Drug Application for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa. Aradigm submitted the NDA for Linhaliq to the FDA in July 2017, following which the FDA set a PDUFA goal date of January 26, 2018 for the completion of its review. "FDA informed us, upon acceptance of our NDA, that they were planning an Advisory Committee for Linhaliq. 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," said Igor Gonda, Ph.D., President and CEO at Aradigm.