The FDA has granted fast track designation to Aradigm’s Pulmaquin dual release inhaled ciprofloxacin for treatment of chronic Pseudomonas aeruginosa lung infections in non-cystic fibrosis bronchiectasis patients, the company said. Aradigm initiated a second Phase 3 trial of Pulmaquin for that indication in June 2014.
The product received Qualified Infection Disease Product (QIDP) status in May 2014, making it eligible for fast track consideration.
Aradigm Chief Medical Officer Juergen Froehlich said, “We are very pleased to receive Fast Track designation for Pulmaquin to address an unmet medical need. In the context of the already granted QIDP designation, it provides us with an outstanding opportunity to expeditiously develop Pulmaquin in non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa. The granting of Fast Track status is an important achievement that can facilitate accelerated review of an NDA submission based on the expected data from our current Phase 3 studies for Pulmaquin with the goal of bringing an important new treatment to these patients as quickly as possible.”
Read the Aradigm press release.
