Posted by Michael Wonder on 11 Dec 2018
Non-cystic fibrosis bronchiectasis FDA grants “fast-track” and “QIPD” to Zambon for colistimethate sodium powder for nebuliser solution delivered by the I-neb AAD system
11 December 2018 - Non–cystic fibrosis bronchiectasis is a, chronic, progressive and irreversible disease, prevalent in Europe and the US.
Zambon announced that colistimethate sodium powder for nebuliser solution, delivered by the I-neb AAD system obtained QIDP and “fast track” designation by the FDA for the indication “prevention of pulmonary exacerbations in adult patients with non-cystic fibrosis bronchiectasis (NCFB) colonised with Pseudomonas aeruginosa”.
Open R&D is conducting two Phase-III pivotal trials in the indication of prevention of pulmonary exacerbations in adult patients with NCFB colonised with Pseudomonas aeruginosa. PROMIS I is being carried out in Europe, Israel, Australia and New Zealand and PROMIS II in North and South America and in Europe. By the end of the first half of 2019, it is expected that overall the two studies will enrol 840 patients.
