FDA Approves Merck & Co.’s Hepatitis C Combo Therapy
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The US Food and Drug Administration (FDA) has approved Merck & Co’s Zepatier (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV).

Zepatier is a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50 mg) and the NS3/4A protease inhibitor grazoprevir (100 mg). The FDA previously granted two breakthrough therapy designations to Zepatier, for the treatment of chronic HCV GT1 infection in patients with end stage renal disease on hemodialysis, and for the treatment of patients with chronic HCV GT4 infection. Breakthrough Therapy designation is given to investigational medicines for serious or life-threatening conditions that may offer substantial improvement over existing therapies.

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 a 2015 Thomson Reuters analysis. Also in that space for 2015 is Merck & Co.'s Zepatier, the HCV combination of grazoprevir and elbasivr, with  projected 2019 sales of $2.167 billion in 2019.

 Also in 2015, the FDA 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.

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.Gilead's Harvoni, an oral combination of sofosbuvir and ledipasvir for treating HCV, was approved and launched in the US in October 2014.

Also in 2015, the FDA approved Bristol-Myers Squibb’s Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is an inhibitor of NS5A with dual modes of anti-viral activity that inhibits both RNA replication and virion assembly. This week, the European Commission approved Daklinza for the treatment of chronic hepatitis C (HCV) in three new patient populations. The expanded label allows for the use of Daklinza in combination with sofosbuvir (with or without ribavirin, depending on the indication and HCV genotype) in HCV patients with decompensated cirrhosis, HIV-1 (human immunodeficiency virus) coinfection, and post-liver transplant recurrence of HCV in all 28 member states of the European Union

Source: Merck & Co.

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