Tags: hepatitis | C | drug | FDA

FDA Approves New Combo Drug for Hepatitis C

FDA Approves New Combo Drug for Hepatitis C
(Copyright DPC)

Tuesday, 28 June 2016 01:28 PM

The U.S. Food and Drug Administration (FDA) has approved a new combination drug that treats all major forms of hepatitis C.

The combination of sofosbuvir and velpatasvir, which is called Epclusa, is the first one to treat the six major genotypes of the infection, which could make it a one-size-fits-all therapy, the FDA says.

"This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C," says Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

Sofosbuvir was approved in 2013, while velpatasvir is a new drug. The combination drug, a fixed-dose tablet, is indicated for patients with chronic hepatitis C infection whether or not they have cirrhosis. However, patients with moderate to severe cirrhosis should use the new drug together with ribavirin, the FDA says.

Like many of the newer hepatitis C drugs, sofosbuvir/velpatasvir does not require concomitant use of interferon, known for its harsh adverse effects. And more important, it is another drug for hepatitis C that achieves a cure rate topping 90 percent with just a 12-week regimen, the agency says.

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A new combination drug that treats all forms of hepatitis C has won approval from the FDA.
hepatitis, C, drug, FDA
Tuesday, 28 June 2016 01:28 PM
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