Medivir AB announced that Health Canada has approved simeprevir for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non‑pegylated) with ribavirin.
Simeprevir received priority review status and is the first treatment for CHC to be approved for once-daily administration with pegylated interferon and ribavirin in Canada.
In Canada, for a drug to receive priority or accelerated review, it must show effective treatment of a serious, life-threatening or severely debilitating disease or condition for which no drug is presently marketed in Canada. Or, it must show a significant increase in efficacy and/or decrease in risk so that the overall benefit/risk profile is improved over existing therapies for a disease that is not adequately managed by a drug already marketed in Canada.
“Canada is the second market where simeprevir has been approved and will be a new agent in the treatment of hepatitis C. The priority review process shows the importance of offering new treatment options also for the hardest to treat patients and we are very happy that both patients and physicians are given new hope,” said Maris Hartmanis, CEO, Medivir.
The approval of simeprevir in Canada is based on four pivotal studies of patients with CHC genotype 1 infection: in treatment-naïve patients (QUEST-1 and QUEST-2), and in patients who have failed prior treatment with pegylated interferon and ribavirin; in PROMISE (prior relapsers) and ASPIRE (prior non-responders).
Results from a pooled analysis of QUEST-1 and QUEST-2 demonstrated that 80% of treatment-naïve patients in the group receiving simeprevir achieved sustained virologic response 12 weeks after the end of treatment (SVR12), compared with 50% of patients in the placebo groups. In PROMISE, 80% of prior-relapser patients in the simeprevir arm of the study achieved SVR12 compared with 37% of patients in the placebo group. Results from ASPIRE demonstrated that use of simeprevir led to sustained virologic response 24 weeks after the end of treatment (SVR24) in 62% of prior partial responder patients and 58% of prior-null responder patients compared with 6% and 15% of prior partial and null-responder patients in the placebo groups, respectively.
Date: November 20, 2013
Source: Medivir
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Simeprevir Approved in Japan and Canada
Simeprevir was approved in Japan September 2013 and in Canada November 20th for the treatment of HCV genotype 1, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non‑pegylated) with ribavirin.
FDA Updates - Sofosbuvir and Simeprevir
Both Drugs Receive Positive FDA reviews by the advisory board
In October the Antiviral Drugs Advisory Committee recommend the approval of Gilead's Sofosbuvir, a nucleotide analog NS5B polymerase inhibitor in combination with just ribavirin for treating adult HCV genotypes 2/3 and in combination with pegylated interferon/ribavirin for genotype 1 and 4 treatment-naive patients and Johnson & Johnson's Simeprevir a protease inhibitor in combination with pegylated interferon and ribavirin for the treatment of adult genotype 1 patients with compensated liver disease, including cirrhosis.
For detailed information please download the FDA review package for sofosbuvir and simeprevir.
The FDA does not have to follow the advice of its panels, but most often does. The U.S. health regulators are scheduled to decide whether to approve sofosbuvir by Dec. 8, and simeprevir by Nov. 27.
Related - Hot Topics
Simeprevir Approved in Japan and Canada
Simeprevir was approved in Japan September 2013 and in Canada November 20th for the treatment of HCV genotype 1, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non‑pegylated) with ribavirin.
FDA Updates - Sofosbuvir and Simeprevir
Both Drugs Receive Positive FDA reviews by the advisory board
In October the Antiviral Drugs Advisory Committee recommend the approval of Gilead's Sofosbuvir, a nucleotide analog NS5B polymerase inhibitor in combination with just ribavirin for treating adult HCV genotypes 2/3 and in combination with pegylated interferon/ribavirin for genotype 1 and 4 treatment-naive patients and Johnson & Johnson's Simeprevir a protease inhibitor in combination with pegylated interferon and ribavirin for the treatment of adult genotype 1 patients with compensated liver disease, including cirrhosis.
For detailed information please download the FDA review package for sofosbuvir and simeprevir.
The FDA does not have to follow the advice of its panels, but most often does. The U.S. health regulators are scheduled to decide whether to approve sofosbuvir by Dec. 8, and simeprevir by Nov. 27.
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