FDA 'Breakthrough' status for Zambon's CMS I-neb

Privately-held Italian drugmaker Zambo today announced that the US Food and Drug Administration has granted Breakthrough Therapy designation to colistimethate sodium powder for nebulization solution (CMS I-neb) for the reduction in the incidence of pulmonary exacerbations in adult patients with non-cystic fibrosis bronchiectasis (NCFB) colonized with P. aeruginosa.

NCFB is a chronic, progressive, and irreversible respiratory disease. There are no approved inhaled treatments currently available for patients with bronchiectasis and chronic P. aeruginosa colonization.

The Breakthrough Therapy designation is supported by data from the Phase III PROMIS - I study, which showed that CMS I-neb significantly reduced the annual rate of exacerbations in patients with NCFB and P. aeruginosa chronic infection, the primary endpoint of the trial. In addition, the trial met important secondary endpoints, including reduction of severe exacerbations and prolongation of time to first exacerbation compared to placebo, and also improvement in Quality of Life (QoL). The treatment was demonstrated to be well tolerated with adverse events similar between groups. Data from the Phase III trial were most recently presented at the European Respiratory Society (ERS) International Congress in September 2021.