Setback for Incivek
Vertex’s Hepatitis C Drug Receives Another Blow With FDA Warning
Published December 19, 2012
Dow Jones Newswires
The Food and Drug Administration on Wednesday placed a new label on Vertex Pharmaceuticals Inc.’s (VRTX) hepatitis C drug Incivek, warning patients that the drug has caused fatal skin rashes in some patients.
Two patients died after developing severe skin rashes while taking Incivek, used to treat the viral liver disease, the FDA said. The warning label, known as a “black box warning” for its prominent placement and black border, is the most serious warning issued by the regulator, and is a further blow to Vertex’s hepatitis C program.
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