The FDA has granted Breakthrough Therapy designation to Zambon’s CMS I-neb colistimethate sodium for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult patients with chronic P. aeruginosa lung infections, the company said. The FDA had previously granted QIDP and Fast Track designations to the colistimethate sodium powder, which is delivered as a solution by the Philips I-neb nebulizer. In September 2021, Zambon announced that the Phase 3 PROMIS-I trial of CMS I-neb in patients with NCFB and P. aeruginosa infection met its primary endpoint.
Zambon CEO Roberto Tascione said, “With no approved drugs for patients with NCFB colonized by P. aeruginosa anywhere in the world, the Breakthrough Therapy designation by FDA marks an important step forward in support of our mission to develop and provide treatment options for people with rare and severe respiratory diseases. We are proud that the FDA has recognized the importance of CMS I-neb and the urgent need to develop innovative treatments for these patients.”
Chief Medical Officer and Head of R&D Paola Castellani commented, “This FDA Breakthrough Therapy designation reinforces our confidence in CMS I-neb, which, if approved, would be the first inhaled treatment for people with NCFB and chronic P. aeruginosa infection. CMS I-neb is a unique inhaled investigational therapy designed to deliver targeted concentrations of drug directly to the site of disease while aiming to minimize systemic exposure that can cause toxicity and side effects. We look forward to working with the FDA over the coming months as we advance the development of CMS I-neb with the hope of bringing much needed benefit to patients whose lives are severely impacted by this disease.”
Read the Zambon press release.
