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Gilead's first pan genotype C cocktail SOF/VEL wins FDA priorityreview

Source:http://www.wisdomdrugs.com Tssuing time:2016-03-25

Hepatitis C giant, Gilead) is developing a type of Pan gene of hepatitis C virus (HCV) cocktail therapy SOF/VEL sofosbuvir/velpatasvir recently in the United States regulatory pass to the good news that the FDA has granted the cocktail therapy treatment of all six genotypes of hepatitis C virus (HCV) of priority review status, review and check cycle will from the conventional 10 months shortened to 6 months, is expected to make this pan genotype C cocktail listed in advance, for the benefit of the majority of U. S. hepatitis C groups.
SOF/VEL a daily service a type of Pan gene of hepatitis C virus (HCV) cocktail therapy, developed for all six genotypes (GT-1, - 2, - 3, - 4, - 5, - 6) in patients with hepatitis C treatment. The Sovaldi hepatitis C drug cocktail by Gilead has listed (sofosbuvir) and another antiviral drug velpatasvir. Among them, sofosbuvir is a nucleoside analog polymerase inhibitor, velpatasvir is a pan gene type NS5A inhibitor.
Gilead in 2015 on October 28th, FDA submitted pan genotype C cocktail SOF/VEL NDA (NDA), the FDA has designated the prescription drug user fee Act (PDUFA) target date of June 28, 2016. Before the breakthrough drug qualification FDA has also been granted for SOF/VEL in all 6 genotypes of hepatitis C. In addition, in the European Union, the EMA has been formally accepted in December 2015 SOF/VEL's listing license application (MAA).
SOF/VEL regulatory documents of the submissions and is based on the four stage III astral clinical study of positive data, these studies in all six genotypes (GT-1, - 2, - 3, - 4, - 5, - 6) hepatitis C groups evaluated the efficacy and safety of SOF/VEL. Data show that the cocktail therapy for all six genotypes of hepatitis C virus (HCV) are effective, including patients with compensated cirrhosis group accompanied by compensatory and decompensated. In the study, 1035 cases of drug pan genotype in hepatitis C patients after 12 weeks, the cure rate reached 98%.
SOF/VEL: will greatly simplify the clinical treatment of hepatitis C, eliminating the necessity of detecting HCV genotype
SOF/VEL as first composed of 2 types of Pan gene, direct acting antiviral drugs (DAAS) Pan genotype C cocktail therapy, marking significant progress in the clinical treatment of hepatitis C virus (HCV). In the United States, genotype 1 hepatitis C is the most common type of hepatitis C; however, in the global scope, more than half of the hepatitis C patients for the other genotypes of hepatitis C virus (HCV).
At present, although the clinical treatment of hepatitis C virus (HCV) has matured, but there are still many patients need a simple and efficient type of Pan gene of HCV drugs, especially very intractable type 3 HCV patients.
SOF/VEL as the first type of Pan gene of hepatitis C virus (HCV) cocktail therapy, will and Gilead current hepatitis C assets and Harvoni sovaldi formed perfect complementary, will provide high clinical cure rate, and is expected to simplify the hepatitis C treatment, more important is, is expected to eliminate the necessity of detection in patients with hepatitis C genotype.
Industry forecasts: SOF/VEL will become the most popular cocktail therapy of hepatitis C in the history
Industry of SOF/VEL of commercial prospects are very promising that this pan genotype C cocktail once listed, will become Gilead HCV assets and a heavy products, and it is likely to become the best-selling hepatitis C drug. At present, there are 2 kinds of drugs Gilead C assets, Sovaldi and Harvoni, which is the main source of income of the company at present. In the first three quarters of 2015, the 2 drugs accounted for more than 60% of the total revenue of the Geely, and Harvoni alone contributed 40% of its sales.
Harvoni itself is an upgraded version of the Sovaldi, listed in October 2014, the current cumulative sales have reached $12 billion 600 million. Sovaldi (sofosbuvir) is by Gilead in 2011 at a cost of $11 billion to acquire pharmasset Inc. obtained. At present, the drug is Gilead HCV assets main active pharmaceutical ingredients.
The unprecedented success of Sovaldi and Harvoni, has helped lay the field of hepatitis C treatment Gilead dominance. Although competitors Aibo Wei in December 2014 launched another a hepatitis C cocktail therapy, but Geely de HCV franchise still occupy the most of the market, continue to control more than 85% of the market share.
However, Gilead C franchises in the market still faces no small pressure. Recent data show that Gilead HCV franchise prescription capacity growth is slowing down, can be safely assumed to be is entering a mature period. But HCV franchise sales decline will directly to the company's revenue stream have a negative impact, thereby creating a new hepatitis C therapy of extreme thirst. It can be said that the listing of the SOF/VEL will be at the right time.


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