FDA panel votes to expand use of Vertex cystic fibrosis drug
(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. The agency is expected to make its decision on the expanded approval by the end of the year, Vertex said.
The current approval of Kalydeco, known chemically as ivacaftor, covers about 2,600 people in North America, Europe and Australia with a different gene mutation. Vertex has forecast 2014 Kalydeco sales of 0 million to 0 million.
Sanford Bernstein analyst Geoffrey Porges said the expanded approval could add about 0 million to annual Kalydeco sales and 50 cents to 55 cents in earnings per share.
Kalydeco was the first drug approved that addresses the underlying cause of cystic fibrosis rather than just the symptoms of the life threatening disease. It helps improve breathing by clearing mucus from the airways.
Vertex is testing other drugs in combination with Kalydeco in hopes of being able to treat a larger portion of the CF population, which affects about 75,000 people in North America, Europe and Australia.
Vertex shares rose 1.6 percent to 9.95 in extended trading from their Nasdaq close at 8.16.
(Reporting by Bill Berkrot; Editing by Diane Craft)
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FDA panel votes to expand use of Vertex cystic fibrosis drug – Reuters
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