FDA panel fails to find Vertex lumacaftor positive for cystic fibrosis

[May 13, 2015]  WASHINGTON (Reuters) - A divided U.S. Food and Drug Administration advisory committee on Tuesday said research data does not show definitively that Vertex Pharmaceutical Inc's drug lumacaftor has a positive effect on cystic fibrosis patients when used in combination with the company's approved therapy, Kalydeco.

The panel reached its decision with only three members voting in favor of efficacy. Four members said data did not show efficacy, while six others said efficacy could not be determined with the data available. The panel is expected to decide within the next hour whether to recommend FDA approval for the combination therapy, which would be sold under the brand name Orkambi.

(Reporting by David Morgan; Editing by Diane Craft)

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