FDA panel votes to expand use of Vertex cystic fibrosis drug

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FDA panel votes to expand use of Vertex cystic fibrosis drug

By Bill Berkrot (Reuters) - A U.S. Food and Drug Administration advisory panel on Tuesday voted 13-2 to recommend expanding approval of Vertex Pharmaceuticals Inc's cystic fibrosis drug Kalydeco to include a wider range of patients with the rare lung disease, the company said. The panel of experts said Kalydeco should be approved for patients ages 6 and older with a specific mutation of the R117H gene, of which there are about 500 people in the United States. The FDA usually follows recommendations of its advisory panels, but is not obligated to do so. ...

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