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CORRECTED-UPDATE 2-AbbVie, Bristol-Myers get FDA nod for hep C treatments
July 24, 2015 / 4:45 PM / 2 years ago

CORRECTED-UPDATE 2-AbbVie, Bristol-Myers get FDA nod for hep C treatments

(Corrects paragraph 6 to say Technivie “comprises three drugs that are included in Viekira Pak”, not “includes the same cocktail of drugs that comprise Viekira Pak”)

July 24 (Reuters) - The U.S. Food and Drug Administration on Friday approved two treatments for less common forms of hepatitis C virus (HCV) infections.

The regulator cleared AbbVie Inc’s Technivie, which targets HCV genotype 4 infections, and Bristol-Myers Squibb Co’s Daklinza, used to treat HCV genotype 3 infections.

About 2.7 million Americans are infected with HCV, of which 10 percent are genotype 3. Genotype 4 is considered among the least common, according to the Centers for Disease Control and Prevention.

Both treatments do not require the co-administration of older antivirals, the regulator said.

The viral disease causes inflammation of the liver that can lead to diminished function or failure of the organ.

Technivie comprises three drugs that are included in Viekira Pak, AbbVie's regimen for the most common form of HCV infection - genotype 1. (1.usa.gov/1gSuFvU)

Technivie is the first regimen approved to safely and effectively treat genotype 4, while Daklinza is the first for genotype 3, the FDA said.

The regulator has approved the use of Daklinza in combination with Gilead Sciences Inc's Sovaldi. (1.usa.gov/1VFlkaX)

Viekira Pak raked in sales of $231 million in the first quarter 2015, while Gilead’s Sovaldi brought in $972 million in the same period. (Reporting by Samantha Kareen Nair in Bengaluru; Editing by Kirti Pandey and Saumyadeb Chakrabarty)

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