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Kalydeco label expansion boosts reach, signals key role for in vitro data

By Michael Fitzhugh
Staff Writer

Friday, May 19, 2017

A surprise FDA approval allowing Vertex Pharmaceuticals Inc. to expand the label for its cystic fibrosis (CF) therapy, Kalydeco (ivacaftor), to include an additional 3 percent of the CF population with certain rare residual function mutations boosted forecast sales for the therapy and lent credence to the potential power of in vitro assays to sway the agency in certain cases.

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