The FDA recently OK'd Viekira XR as a treatment for hepatitis C. | Courtesy of Shutterstock
+ Regulatory
Amanda Rupp | Jul 27, 2016

FDA approves Viekira XR to treat hepatitis C

AbbVie, a worldwide biopharmaceutical company, recently announced that it has gained approval from the U.S. Food and Drug Administration (FDA) to use its once-daily Viekira XR formula to treat genotype 1 chronic hepatitis C.

This extended-release formulation is the first of its kind as an all-oral, co-formulated treatment. It includes three direct-acting antiviral elements for adults who have genotype 1 chronic hepatitis C infections. The treatment regimen is three oral tablets that need to be swallowed with meals.

FDA officials approved the new drug application based on evidence from phase-three clinical trials. These studies featured data that showed a 100 percent sustained virologic response within 12 weeks of receiving the treatment.

AbbVie sees this as evidence of the company’s ongoing dedication to developing and marketing therapeutic innovation for people who have HCV infections.

"AbbVie's work continues to contribute to the transformation of hepatitis C care through our focus on evolving our current therapies as part of our ongoing commitment to patients," Dr. Rob Scott, vice president of development and chief medical officer for AbbVie, said. "The approval of Viekira XR provides a new treatment option for genotype 1 hepatitis C patients in the U.S. with clinical trial data using the components of Viekira XR demonstrating 100 percent cure rates in genotype 1b patients."

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+ Abbvie

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