Zambon has announced that its colistimethate sodium powder for nebulized delivery as a solution by the Philips i-neb nebulizer system, has received QIDP and fast track designations from the FDA for the prevention of exacerbations in non-cystic fibrosis bronchiectasis patients with P. aeruginosa lung infections.
The company said that two Phase 3 studies of colistimethate sodium powder for nebulizer solution for this indication are underway, and submission of a regulatory filing is expected in the second half of 2021. Zambon acquired Profile Pharma and its Promixin nebulized colistimethate sodium from Philips in 2013.
Zambon CEO Roberto Tascione commented, “With our Phase 3 trial on non-cystic fibrosis bronchiectasis, we are among the very few companies committed to continue to develop a treatment against this disease with the aim of offering new prospects to the patients with the seriously disabling disease NCFB.”
Xellia will make the drug for clinical trials. Xellia International President Gaël Bernard said, “As the world’s leading supplier of colistimethate sodium we are excited to expand our long-time partnership with Zambon to also provide to patients this important drug product for the new indication of non-cystic fibrosis bronchiectasis.”
Read the Zambon press release.
