EC OKs Expanded Use of BMS’ Hepatitis C Drug
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The European Commission has approved Bristol-Myers Squibb 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.

Daklinza is already approved by the European Commission for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic HCV infection in adults, and the Daklinza + sofosbuvir regimen is an approved 12-week, all-oral treatment for genotype 3 HCV patients without cirrhosis. Daclatasvir-based regimens have been approved in more than 50 countries across Europe, Central and South America, the Middle East and the Asia-Pacific region.

In 2015, the FDA approved Daklinza 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. 

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, which was approved in January 2016, 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.

Source: Bristol-Myers Squibb

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