Monday 9 December 2013

FDA and EMEA approve of Game Changer Sofosbuvir 

 Sofosbuvir is a first-in-class polymerase inhibitor that allows for   all-oral, interferon-free therapy for some patients with hepatitis  C and reduced treatment time for most.

The US Food and Drug Administration (FDA) has approved the first-in-kind nuceotide analog inhibitor sofosbuvir (Sovaldi, Gilead Sciences, Inc) for the treatment of adults with chronic hepatitis C virus (HCV) infection, a widely anticipated move that is expected to dramatically improve outcomes for many patients.

The European Medicines Agency's Committee for Medicinal Products for Human use (CHMP) has recommended granting a marketing authorisation for Sovaldi (sofosbuvir), for use 'in combination with other medicinal products for the treatment of chronic (long-term) hepatitis C in adults'.

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