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Gilead’s Hepatitis C Drug Sofosbuvir Gets EMA Positive Opinion 2013-11-22 13:35:03.844 GMT
By Sheela Sharma Nov. 22 (Bloomberg) -- Gilead’s Sovaldi (sofosbuvir, GS-7977) for treatment of hepatitis C (HCV) gets a positive recommendation. * NOTE: MAA application was for use in an interferon-free regimen with ribavirin in hepatitis C genotype 2 and 3 treatment naive patients, interferon intolerant and experienced patients, and for combination with peg- interferon and ribavirin in hepatitis genotype 1, 4, 5 and 6 treatment naive patients * NOTE: Got EMA recommendation for use as part of a compassionate-use program for treatment of adults with hepatitis C on Oct. 25 * NOTE: Oct. 25, won FDA panel vote for treatment in combination with ribavirin to treat hepatitis C genotypes 1, 2, 3 and 4; Pdufa date Dec. 8
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--Editor: James Ludden
To contact the reporter on this story: Sheela Sharma in London at +44-20-7392-0395 or ssharma145@bloomberg.net
To contact the editor responsible for this story: James Ludden at +44-20-7673-2645 or jludden@bloomberg.net