Health Canada approves Vertex' Kalydeco; and Sanofi Pasteur's Menactra

Vertex Pharmaceuticals (Nasdaq: VRTX) says that Health Canada has approved Kalydeco (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), for people aged six and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

The approval of Kalydeco was based on data from two global Phase 3 studies of people with CF who have at least one copy of the G551D mutation. Those who were treated with KALYDECO experienced significant and sustained improvements in lung function and weight gain compared to those who received placebo. In one study, people who took Kalydeco were also significantly less likely to experience pulmonary exacerbations, which are periods of worsening respiratory signs and symptoms that often require treatment with antibiotics and hospital visits.

Peter Mueller, scientific officer and executive vice president of global R&D at Vertex, commented: “We are working closely with federal, provincial and territorial governments and private health insurers to bring Kalydeco to all eligible Canadians with cystic fibrosis who have the G551D mutation.”