FDA approves Gilead's first all genotypic hepatitis C new drug Epclusa

From:Biological Valley Date:2017-04-20 10:47

June 29, 2016 - Gilead, a ubiquitous genotypic hepatitis C cocktail therapy in the field of hepatitis C, has made a major milestone in the US regulation, Epclusa. FDA has approved Epclusa for the treatment of all 6 genotypes of hepatitis C.

This approval made Epclusa the first and only global treatment for hepatitis C, the only full oral, ubiquitous, single tablet, and it was also the third hepatitis C drug based on sofosbuvir (Soffe Bbu Vee) developed by Gilead.
In addition, Epclusa is the first single tablet solution approved for the treatment of genotype 2 and genotype 3 hepatitis C (there is no need to combine Leigh Bhave Lin). The approval of Epclusa marks significant progress in the clinical treatment of hepatitis C. Prior to that, FDA has awarded Epclusa a breakthrough drug qualification and priority qualification.
The Epclusa treatment program approved by FDA is:
(1) Epclusa monotherapy for 12 weeks for hepatitis C patients without cirrhosis or compensated cirrhosis (Child-Pugh a).
(2) Epclusa combined with Leigh Bhave Lin (RBV) for 12 weeks for hepatitis C patients with decompensated cirrhosis (Child-Pugh B or C grade).
Epclusa will greatly simplify the clinical treatment of HCV and eliminate the necessity of detecting HCV genotype.
Epclusa (sof/vel), the first pan gene type hepatitis C cocktail therapy, will complement the current hepatitis C assets (Sovaldi and Harvoni) in Gilead, which will provide a high clinical cure rate, and is expected to simplify the treatment of hepatitis C, and more importantly, it is expected to eliminate the necessity of detecting the genotype of hepatitis C in patients.
Industry forecast: Epclusa (sof/vel) will become the best selling hepatitis C cocktail in history.
At present, there are 2 kinds of drugs, Sovaldi and Harvoni in Gilead's hepatitis C assets, and the unprecedented success of these 2 drugs has helped Gileadto lay the absolute supremacy in the field of hepatitis C treatment. Although rival ALB Ivy launched another hepatitis C cocktail therapy at the end of 2014, the Gileadhepatitis C franchise continues to control over 85% of the market share.
Epclusa (sof/vel) is a Gilead third sofosbuvir based hepatitis C cocktail, and the industry is very promising for the commercial prospects of the drug. Once the pan genetic type of hepatitis C cocktail is listed, it will become another heavy product of Gilead's hepatitis C assets and can be the best selling hepatitis C drug in history.