Vertex Pharma Submits SNDA To FDA For KALYDECOTM Monotherapy - Quick Facts

(RTTNews) - Vertex Pharmaceuticals Incorporated (VRTX) announced the submission of a supplemental New Drug Application, or sNDA, to the U.S. FDA for the approval of KALYDECOTM monotherapy for people with cystic fibrosis ages 6 and older who have at least one non-G551D gating mutation in the cystic fibrosis transmembrane conductance regulator gene.

The comapny said the sNDA submission is based on the data from a Phase 3 study of ivacaftor monotherapy that showed statistically significant improvements in lung function. The safety and tolerability results were consistent with those observed in prior Phase 3 studies of ivacaftor monotherapy in people with cystic fibrosis who have the G551D mutation.