Vertex Pharmaceuticals Incorporated received favorable news when the FDA’s Pulmonary Allergy Drugs Advisory Committee (PADAC) voted in favor (13-2) of clearing the company’s cystic fibrosis (CF) drug Kalydeco in the US for an additional patient population.
Vertex Pharma is looking to get Kalydeco approved for the treatment of patients (six years of age and above) with CF who have the R117H mutation in the cystic fibrosis transmembrane regulatory (CFTR) gene.
A response from the FDA is expected by Dec 30, 2014.
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