FDA panel fails to find Vertex lumacaftor positive for cystic fibrosis

May 12, 2015 7:30 PM

8 0

WASHINGTON May 12 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...

Read more

To category page