The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) will meet on May 8, 2019 to consider Chiesi’s NDA for Bronchitol mannitol DPI for the treatment of cystic fibrosis.
According to Bronchitol developer Pharmaxis, its partner Chiesi resubmitted the NDA in December 2018. Bronchitol was approved for the treatment of CF in Europe in 2012, but the FDA issued a complete response letter to the original NDA in 2013.
The 2013 CRL stated that the FDA found the clinical data insufficient to support approval and requested an additional clinical trial. Pharmaxis said in February 2017 that it had completed the new Phase 3 trial, and in June of that year said that the trial met its endpoint but that lung function improvements were less than demonstrated in previous Phase 3 trials in adults.
View the FDA announcement.
