Information regarding use in patients with chronic infection. 9. As there is very limited Novartis does not consider it The RMP evaluator information available about necessary to add who are maintains the opinion ‘women the safety of the product for breastfeeding’ to the missing that who are ‘women women who are information in the table of ongoing breastfeeding’ should breastfeeding, this patient safety concerns of the proposed RMP. be added as missing group should be added as This position is based on the information in the missing information in the appropriate wording provided in the table of ongoing table of ongoing safety current proposed Product Information safety concerns. concerns as missing as shown below. information. 10. As there is very limited Novartis does not consider it This is considered information available about necessary to add patients acceptable. ‘elderly the safety of the product for (aged>75 years)’ as missing very elderly patients (aged information in the table of ongoing >75 years), this patient group safety concerns of the proposed RMP. should be added as missing The secukinumab clinical program information in the table of included: ongoing safety concerns. Over 5,044 patients, including 4,498 patients who were treated with secukinumab in blinded and open-label clinical studies in various indications (plaque psoriasis and other autoimmune conditions) in 39 clinical studies. Psoriasis Program: 4,546 patients were studied to support the that secukinumab is safe and effective in adults with moderate to severe plaque psoriasis in 10 Phase II/III studies. This represents the largest registration program for a biologic for the treatment of psoriasis to date. Across the psoriasis trials, the majority of patients were < 65 years of age. Of the 3,430 plaque psoriasis patients exposed to secukinumab in clinical studies, a total of 230 were 65 years of age or older and 32 patients were 75 years of age or older. This is a significant number of elderly patients for a new psoriasis product. From an efficacy perspective, this product is effective in the elderly population, as stated in the sponsor’s summary of clinical efficacy.
Information regarding use in patients with chronic infection. 9. As there is very limited information available about the safety of the product for women who are breastfeeding, this patient group should be added as missing information in the table of ongoing safety concerns as missing information. Novartis does not consider it necessary to add ‘women who are breastfeeding’ to the missing information in the table of ongoing safety concerns of the proposed RMP. This position is based on the appropriate wording provided in the current proposed Product Information as shown below. The RMP evaluator maintains the opinion that ‘women who are breastfeeding’ should be added as missing information in the table of ongoing safety concerns. 10. As there is very limited information available about the safety of the product for very elderly patients (aged >75 years), this patient group should be added as missing information in the table of ongoing safety concerns. Novartis does not consider it necessary to add ‘elderly patients (aged>75 years)’ as missing information in the table of ongoing safety concerns of the proposed RMP. The secukinumab clinical program included: Over 5,044 patients, including 4,498 patients who were treated with secukinumab in blinded and open-label clinical studies in various indications (plaque psoriasis and other autoimmune conditions) in 39 clinical studies. Psoriasis Program: 4,546 patients were studied to support the that secukinumab is safe and effective in adults with moderate to severe plaque psoriasis in 10 Phase II/III studies. This represents the largest registration program for a biologic for the treatment of psoriasis to date. Across the psoriasis trials, the majority of patients were < 65 years of age. Of the 3,430 plaque psoriasis patients exposed to secukinumab in clinical studies, a total of 230 were 65 years of age or older and 32 patients were 75 years of age or older. This is a significant number of elderly patients for a new psoriasis product. From an efficacy perspective, this product is effective in the elderly population, as stated in the sponsor’s summary of clinical efficacy. This is considered acceptable.
auspar-secukinumab-150916.docx