Regulatory Decision Summary for Galexos
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this Supplemental New Drug Submission for Galexos was to expand the treatment indication for use in adult patients (≥18 years of age) with chronic hepatitis C virus genotype 4 infection in combination with sofosbuvir.
Why was the decision issued?
Health Canada considers that the benefit/risk profile of Galexos (simeprevir, SMV) is favourable when used as directed in the treatment of chronic hepatitis C virus genotype 4 infection (CHC GT4) in adult patients with compensated liver disease including cirrhosis.
The indication is based on supporting results from two clinical studies in CHC GT4 patients who were treatment-naïve or peginterferon (PegIFN) and/or ribavirin (RBV) treatment-experienced with or without cirrhosis.
The efficacy of Galexos was assessed by measuring the sustained virologic response rate at follow-up Week 12 (SVR12). Galexos was found to demonstrate 100% SVR12. The treatment was well tolerated for these patients who received Galexos plus sofosbuvir (SOF) daily for 12 weeks. The overall adverse event (AE) profiles from Galexos plus SOF treatment for 12 weeks appeared similar to those CHC GT1 patients receiving same treatment regimens. The combination of Galexos and SOF has a more favorable AE profile than treatment with PegIFN and/or RBV.
The expanded indication would benefit to CHC GT4 patients who are treatment-naïve or PegIFN and/or RBV-experienced or -intolerant. It is unclear whether there are clinical benefits in patients CHC GT4 who were Direct Acting Antiviral Agents (DAAs) treatment-experienced (including HCV viral non-structure region 3 or 4A [NS3/4A] protease inhibitors, non-structure region 5A [NS5A] or NS5B inhibitors) due to the limitation of these trials. It is also uncertain from the trial results whether patients with baseline polymorphism/substitutions at NS3/4A or NS5A region of the viral genomes might impact treatment results.
Based on the data submitted, Health Canada considers that the anticipated benefits of treatment regimen of combination of Galexos and SOF in CHC GT4 adult patients with compensated liver disease including cirrhosis outweigh the potential risks under the conditions of use described in the Galexos Product Monograph.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.