individual. Therefore, the sponsor does not consider it warranted to add acute hypersensitivity reactions as an Important Potential Risk in the simeprevir RMP. The Sponsor should add the Details of sponsor’s full The OPR evaluator following important missing response and justification acknowledges the sponsor’s information: are not included here. response regarding the inclusion of these areas of Off-label use, including missing information. use in the absence of pegIFN and/or RBV, or However, the with interferon drugs recommendation remains to other than PegIFNα. include the following two areas of important missing Use in HCV information: genotypes Use in HCV genotypes Patient’s with previous triple Use in patients of Aboriginal therapy and Torres Strait Islander simeprevir/PegIFN/ descent RBV treatment failure Long term therapy Exposure in patients with psychiatric disorders Use in patients of Aboriginal and Torres Strait Islander descent Use in patients with HIV co-infection The following important As mentioned above, The safety of simeprevir identified risks are known identified risks of PegIFN cannot be separated from to be associated with and/or RBV which are not that of pegIFN and RBV as pegIFN and RBV treatment attributable to simeprevir, these products are dosed (as agreed by the sponsor in are not listed as important together as part of triple the RMP): identified risk or important therapy. potential risk in the Psychiatric disorders This of including simeprevir RMP. important risks related to Diabetes mellitus pegIFN and RBV treatment Thyroid disorders is deferred to the Delegate for consideration. Specific skin disorders (cutaneous leukocytoclastic vasculitis, lichen planus, polyarteritis nodosa, porphyria cutanea
individual. Therefore, the sponsor does not consider it warranted to add acute hypersensitivity reactions as an Important Potential Risk in the simeprevir RMP. The Sponsor should add the following important missing information: Off-label use, including use in the absence of pegIFN and/or RBV, or with interferon drugs other than PegIFNα. Use in HCV genotypes Patient’s with previous triple therapy simeprevir/PegIFN/ RBV treatment failure Long term therapy Exposure in patients with psychiatric disorders Use in patients of Aboriginal and Torres Strait Islander descent Use in patients with HIV co-infection Details of sponsor’s full response and justification are not included here. The OPR evaluator acknowledges the sponsor’s response regarding the inclusion of these areas of missing information. However, the recommendation remains to include the following two areas of important missing information: Use in HCV genotypes Use in patients of Aboriginal and Torres Strait Islander descent The following important identified risks are known to be associated with pegIFN and RBV treatment (as agreed by the sponsor in the RMP): Psychiatric disorders Diabetes mellitus Thyroid disorders Specific skin disorders (cutaneous leukocytoclastic vasculitis, lichen planus, polyarteritis nodosa, porphyria cutanea As mentioned above, identified risks of PegIFN and/or RBV which are not attributable to simeprevir, are not listed as important identified risk or important potential risk in the simeprevir RMP. The safety of simeprevir cannot be separated from that of pegIFN and RBV as these products are dosed together as part of triple therapy. This of including important risks related to pegIFN and RBV treatment is deferred to the Delegate for consideration.
auspar-simeprevir-141027.docx