Zambon’s CMS I-neb Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Non-Cystic Fibrosis Bronchiectasis
Shots:
- The US FDA has granted BTD to colistimethate sodium powder for nebulization solution (CMS I–neb) in adult patients with NCFB colonized with P. aeruginosa
- The designation was based on the P-III (PROMIS – I) study which showed that CMS I-neb can reduce the annual rate of exacerbations. The trial also met 2EPs including reduction of sev. exacerbations & prolongation of time to first exacerbation over PBO along with an improvement in QoL & were well tolerated with similar AEs
- MS I–neb is an inhaled therapy & is designed to deliver targeted concentrations of drug to the site of disease to minimize systemic exposure. If approved, it will be 1st inhaled treatment for people with the same indication
Ref: PR Newswire | Image: Wikipedia
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