TRIP

FDA Approves Cystic Fibrosis Drug

MedPageToday, 2012

in the New England Journal of Medicine , lung function as measured by forced expiratory volume in one second (FEV1) improved by 10.6 percentage points with ivacaftor relative to placebo.
The drug was also associated with greater reductions in pulmonary exacerbations and respiratory symptoms, as well as better weight gain in the study.
Patients with cystic fibrosis often have difficulty maintaining normal weight and are excessively thin.
Common side effects with ivacaftor include upper respiratory tract infection, headache, stomach ache, rash, diarrhea, and dizziness, the FDA said.
Because ivacaftor is proven to be effective only in patients with the G551D mutation, patients' genotype should be determined before starting therapy, the FDA added.
The company said it was evaluating a combination of ivacaftor and a different drug that Vertex believes could help patients with the more common delta F508-CFTR mutation.
Vertex said it would provide the drug free of charge to patients with household income of $150,000 or less who do not have insurance.
For those with insurance, the company said, "there will be a minimal out-of-pocket obligation after which Vertex will help cover copay or coinsurance costs up to 30% of the list price of the medicine.
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