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Gilead Submits NDA for Hepatitis C Combo (GILD)

A single-tablet, three-drug combo for hepatitis C treatment is under consideration for approval by the FDA.

Gilead Sciences Inc. (GILD) filed a new drug application (NDA) with the Food And Drug Administration (FDA) for a single-tablet, three-drug combination involving its Sofosbuvir, Velpatasvir and Voxilaprevir drugs to treat genotype 1-6 hepatitis C.

The NDA follows the positive results of four different Phase 3 studies in October 2016. The results were presented at the American Association for the Study of Liver Diseases in November. The new drug application marks on-track progress by the Foster City, California-based company for its hepatitis C combination therapy. (For more, see Gilead’s Hep C Phase 3 Shows Good Outcomes.)

Chronic hepatitis C virus infection (HCV) is a long-term disease that can lead to liver cancer and cirrhosis (scarring of the liver). Genotypes are classifications of HCV based on genetics, with genotype 1 being the most common and the most difficult to treat.

The three-drug therapy offers a convenient, once-daily single-tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg. The combination has secured a breakthrough therapy designation from the FDA for treating chronic genotype 1 HCV patients who have previously failed an NS5A inhibitor-containing regimen.

Read full article: Gilead Submits NDA for Hepatitis C Combo (GILD) | Investopedia

Read Full Article: Gilead Submits NDA for Hepatitis C Combo (GILD) | Investopedia

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