Kombinētais preparāts C hepatīta ārstēšanai rekomendēts pielietošanai Eiropas Savienībā
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27.09.2014
Gilead Sciences announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CMHP) adopted a positive opinion related to a marketing application for Harvoni (ledipasvir/sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection in adults. The company noted that the CHMP's decision was made after an accelerated review procedure.
The once-daily oral drug is a fixed-dose combination of the NS5A inhibitor ledipasvir and the nucleotide analogue polymerase inhibitor sofosbuvir, which was approved as a single agent by the European Commission in January and is marketed as Sovaldi. Gilead said the latest decision is supported by data from the late-stage ION-1, ION-2 and ION-3 studies, which evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2000 genotype 1 HCV patients with compensated liver disease. The studies included cirrhotic and non-cirrhotic patients who were new to HCV treatment and those who had failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
Read more at http://www.firstwordpharma.com/node/1237152?tsid=28#axzz3ES33GHix
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