GILD Sofosbuvir Gets Accelerated EMA Validation. Fly On The Wall Link
Fly On the Wall May 21, 2013
May 21, 2013
16:51 EDT GILD Gilead's sofosbuvir gets EMA validation, now under assessment
Gilead Sciences announced that the company’s Marketing Authorisation Application, or MAA, for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus infection, which was submitted to the European Medicines Agency, or EMA, on April 17, has been fully validated and is now under assessment. The data submitted in this MAA support the use of sofosbuvir and ribavirin as an all-oraltherapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.