Abbvie’s HCV Regimen Receives FDA “Breakthrough Therapy” Designation

Today AbbVie announced that its investigational direct-acting antiviral (DAA) combination with and without ribavirin for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection has been designated as a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA).

According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy designation includes preliminary clinical evidence demonstrating a drug may have substantial improvement on at least one clinically significant endpoint compared to available therapy. A Breakthrough Therapy designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program.

“AbbVie is pleased that the FDA has granted Breakthrough Therapy designation to our 3-DAA combination with and without ribavirin. We feel it reflects the potential of this regimen to be important in the treatment of HCV,” said John M. Leonard, M.D., senior vice president and chief scientific officer, AbbVie. “Our HCV program is one part of our advancing pipeline which is focused on delivering innovative therapies to address pressing areas of unmet clinical need.”

About the Hepatitis C Virus

Across the world, about 160 million people are chronically infected with hepatitis C.(2) Hepatitis C is an inflammation of the liver caused by an infection with the hepatitis C virus (HCV).(3) HCV is transmitted when an infected person’s blood enters the bloodstream of another person.(4)

For the hepatitis C virus, there are six major HCV genotypes (GT1-6). Presently, there is no vaccine for the hepatitis C virus (HCV) infection. Decision to treat is dependent on a number of factors such as the amount of liver damage present, other conditions the patient may have, amount of virus in the body, and viral genotype. If treatment is needed, a hepatitis C infection is typically treated with a combination of antivirals.

Click Here for a link to the press release.

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