FDA OKs New Uses for BMS’ Hepatitis C DrugBy
The US Food and Drug Administration has approved Bristol-Myers Squibb’s Daklinza (daclatasvir, 60 mg), an NS5A replication complex inhibitor, in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3 chronic hepatitis C virus (HCV). The expanded label includes three additional patient populations: HCV patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is a 12-week, once-daily all-oral treatment option for these patients.
In July 2014, Japan became the first country in the world to approve the use of a daclatasvir-based regimen for the treatment of chronic hepatitis C. Since then, 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.
Daklinza is competing in the HCV market. 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.
Source: Bristol-Myers Squibb