FDA Approves AbbVie’s Hepatitis C Drug TechnivieBy
The US Food and Drug Administration (FDA) has approved AbbVie’s Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for treating hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).
Technivie in combination with ribavirin was approved to treat genotype 4 HCV infections without the need for co-administration of interferon, an FDA-approved drug also used to treat HCV infection.
Technivie is the second oral hepatitis C drug by AbbVie to be approved by the FDA. In 2014,the FDA approved AbbVie’s Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with HCV genotype 1 infection, including those with a cirrhosis.
The competition in the HCV market is strong. In 2013, Gilead Sciences received FDA approval for Sovaldi (sofosbuvir) to HCV infection, the first drug oral drug to treat certain types of HCV infection without the need for co-administration of interferon as a component of a combination antiviral treatmen regimen. Solvadi was approved to treat subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.
Sovaldi was Gilead's top-selling drug in 2014 and was one of the industry's top-selling drugs with 2014 sales of $10.28 billion, making it one of the most successful first-year launches for a new molecular entity. Sovaldi, which was approved by the FDA in December 2013 and in the European Union in January 2014, was the first drug that demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon, which is administered by injection. Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate, and that mechanism of action was considered an important advancement as well as the ability to administer the drug orally. The drug is forecasted to have sales of $10.5 billion in 2015, dropping slightly, and rise to $12.0 billion in 2019. Gilead's Harvoni, an oral combination of sofosbuvir and ledipasvir for treating HCV, was approved and launched in the US in October 2014.
The competition in the HCV market is strong. AbbVie's Viekira Pak (veruprevir, ritonavir, ombitasvir, and dasabuvir) is an all oral HCV regime with projected 2019 sales of $2.5 billion, which will compete against Gilead Science's Harvoni (combination of sofosbuvir and ledipasvir), according to the Thomson Reuters analysis. Also in that space for 2015 will be Merck & Co.'s HCV combination of grazoprevir and elbasivr, with a US filing planned in 2015 and first sales in 2016 and projected 2019 sales of $2.167 billion expected in 2019.