FDA Examiner: the new hepatitis C drug sofosbuvir is safe and effective

Source: Biovalley 2013-10-24 FDA examiner said on October 23 that sofosbuvir, a hepatitis C drug developed by Gilead, is safe and effective when used in combination with other therapies for hepatitis C FDA inspectors released the review information on their website on Wednesday, and the FDA's external advisory committee will hold a meeting on October 25 to vote on whether to recommend approval of sofosbuvir According to FDA reviewers, the clinical data currently available supports sofosbuvir as a part of the combination therapy for the treatment of chronic hepatitis C (CHC) when it is used for the assessment of beneficial benefit risk In addition, so far, no major security issues related to sofosbuvir have been found Sofosbuvir is a daily oral nucleoside analogue inhibitor developed for the treatment of chronic hepatitis C virus (HCV) infection Gilead submitted the new drug application (NDA) of sofosbuvir in April 2013, and FDA granted sofosbuvir NDA priority qualification in June 2013 The data contained in sofosbuvir NDA supports the use of sofosbuvir and ribavirin (RBV) as an all oral therapy for genotype 2 and 3 HCV infection, and the use of sofosbuvir and ribavirin, PEG-IFN for genotype 1, 4 and 6 HCV infection If approved, sofosbuvir will become an important part of the first all oral combination therapy for hepatitis C and is expected to eliminate the need for traditional injectable drugs Gilead estimates that once sofosbuvir goes public, its market value will be $11 billion