to the pediatric population as well for the purpose of labeling. The sponsor agrees that adequate data are not available for children younger than 2 years and will include this age category as important missing data in the RMP.’ The sponsor should conduct a initial concern over the This is not ‘The study (or assign an existing relationship of insulin glargine considered study) to investigate the and malignancy was raised in acceptable. potential risk of malignancies 2009 in a published further, in particular in The OPR Pharmacoepidemiology survey. children. evaluator Sanofi-Aventis, the Lantus® acknowledges sponsor, conducted 3 additional that the reported surveys, covering a total of almost incidence of 2 million patient lives, to explore malignancy is low this question, with conflicting and that a results. In addition, Sanofi altered paediatric the secondary endpoints of the diabetic ORIGIN study, a 12,000-patient, population is prospective, 6 year longitudinal receiving more study in prediabetic and diabetic medical patients to explore the incidence monitoring. of malignancy and also conducted a prospective study in patients However, with breast cancer who were considering that newly diagnosed as diabetic and many paediatric were insulin naïve. This study was malignancies may planned after Committee for be discovered late, Medicinal Products for Human that medical Use (CHMP) concluded that the monitoring for diabetes not other potential risks of a causal relationship between the use of necessarily insulin analogues and malignancy increase the had apparently been discharged. probability of detecting a The CHMP report from 31 May 2013 concluded overall the malignancy, and ‘that data did not indicate an increased that insulin risk of cancer with insulin glargine is a widely used medicine, the glargine, noting that there is no known mechanism by which the sponsor should insulin glargine would cause conduct a study (or cancer and that a cancer risk has assign an existing study) to not been seen in laboratory studies.’ investigate the potential risk of Neither the initial report nor any malignancies in subsequent reports have reported children further. an increased risk of malignancy in children insulin analogues. This The paediatric diabetic recommendation population is increasing in remains. prevalence but remains small, and the number of diabetic children who either have or are likely to develop a malignancy is also quite
to the pediatric population as well for the purpose of labeling. The sponsor agrees that adequate data are not available for children younger than 2 years and will include this age category as important missing data in the RMP.’ The sponsor should conduct a study (or assign an existing study) to investigate the potential risk of malignancies further, in particular in children. ‘The initial concern over the relationship of insulin glargine and malignancy was raised in 2009 in a published Pharmacoepidemiology survey. Sanofi-Aventis, the Lantus® sponsor, conducted 3 additional surveys, covering a total of almost 2 million patient lives, to explore this question, with conflicting results. In addition, Sanofi altered the secondary endpoints of the ORIGIN study, a 12,000-patient, prospective, 6 year longitudinal study in prediabetic and diabetic patients to explore the incidence of malignancy and also conducted a prospective study in patients with breast cancer who were newly diagnosed as diabetic and were insulin naïve. This study was planned after Committee for Medicinal Products for Human Use (CHMP) concluded that the other potential risks of a causal relationship between the use of insulin analogues and malignancy had apparently been discharged. The CHMP report from 31 May 2013 concluded ‘that overall the data did not indicate an increased risk of cancer with insulin glargine, noting that there is no known mechanism by which the insulin glargine would cause cancer and that a cancer risk has not been seen in laboratory studies.’ Neither the initial report nor any subsequent reports have reported an increased risk of malignancy in children insulin analogues. The paediatric diabetic population is increasing in prevalence but remains small, and the number of diabetic children who either have or are likely to develop a malignancy is also quite This is not considered acceptable. The OPR evaluator acknowledges that the reported incidence of malignancy is low and that a paediatric diabetic population is receiving more medical monitoring. However, considering that many paediatric malignancies may be discovered late, that medical monitoring for diabetes not necessarily increase the probability of detecting a malignancy, and that insulin glargine is a widely used medicine, the sponsor should conduct a study (or assign an existing study) to investigate the potential risk of malignancies in children further. This recommendation remains.
auspar-insulin-glargine-150828.docx