Gilead Sciences announced that it received a positive opinion from the Committee of Medicinal Products for Human Use (CHMP), a European Medicines Agency (EMA) Scientific community on its Marketing Authorization Application (MAA) for Epclusa. This drug contains 400 mg of nucleotide analogue polymerase inhibitor sofosbuvir (SOF), 100 mg of velpatasvir (VEL) and NS5A inhibitor which are used to target all genotypes of chronic hepatitis C infection. Epclusa can be taken orally as one-tablet for daily dosing.
In their application, Gilead Sciences supported the use of Epclusa for adult patients suffering from chronic hepatitis C infection. CHMP’s positive opinion hopes to accelerate the review process of the drug.
CHMP works specifically on identifying medicinal products that are expected to be of great potential for the public interest.
The company shared that their review is now forwarded to the European Commission, which has the sole authority to approve the medicine. If granted, the drug will be distributed to the 28 member countries of the European Union including Iceland and Norway.
Gilead Sciences also submitted a regulatory application to the US Regulatory Board for SOF/VEL. The company applied for NDA on October 28 last year under the PDUFA or Prescription Drug User Fee Act and they are expecting to get the result on the 28th of June.
Gilead Sciences also noted that Epclusa is still an investigational product so the efficacy and safety of the drug has not been established.
The company also added that the Marketing Authorization Application (MAA) for Epclusa is supported by four Phase 3 Studies. The initial three clinical trials have 1,035 patients having 1 to 6 genotypes of HCV infection with compensated cirrhosis (Child-Pugh A) or without cirrhosis. The participants of this clinical trial received 12 weeks of Epclusa treatment.
Understanding the Burden of Hepatitis C Infection
Hepatitis C infection is the leading cause of liver cirrhosis, hepatocellular carcinoma, and it is a major indication for liver transplantation. According to the National Health and Nutrition Examination Survey (NHANES), from 1999 to 2002, 1.6% of the population was infected with Hepatitis C virus. In a recent study, more than 15,000 deaths were recorded in 2007 due to hepatitis C infection. It is believed that these data already exceeded the earlier estimates.
Hepatitis C virus infection shows high genetic diversity. The disease is characterized by variations in the genotype prevalence. This posed a great challenge to the development of pan-genotypic treatments and vaccines.
So, there is need to require biopharmaceutical companies who wants to work on this drug to consider the global trends of HCV genotype.
The End Result
There is a need to have a better understanding of the disease progression of Chronic Hepatitis C infection and how it can impact the treatment plans. There is also a call to develop effective therapeutic strategies to create a potent therapy for HCV infection.
The good review on Epclusa offers an encouraging development in treating Hepatitis C infection. As the drug targets all genotypes of Hepatitis C, the medical community is optimistic that this will eventually prevent the continuing spread of the infection.
Messina, J. P. (2015). Global Distribution and Prevalence of Hepatitis C Virus Genotypes. Hepatology , 77–87.
Razavi, H. (2013). Chronic Hepatitis C Virus (HCV) Disease Burden and Cost in the United States. Hepatology , 2164–2170.