Novo Nordisk has announced that the Human Use Medicines Committee (CHMP) has issued a positive opinion to extend the use of Novorapid ® (Insulina Aspart) in the European Union to children with diabetes from a year of age.
In Europe there are about 140,000 children with type 1 diabetes and scientific evidence shows that this pathology is diagnosed increasingly at earlier ages.The clinical needs of children with type 1 diabetes vary during their growth and development, which can be a challenge for doctors in search of appropriate treatment that maintains adequate metabolic control while avoiding the unnecessary risk of hypoglycemia.
"Until now, a quick action insulin has not been approved for the time of children's foods with diabetes from one year-Professor Thomas Danne, of the AUF Der Bult de Hannover (Germany) Children's Hospital (Germany).Novorapid ® has an efficacy profile, proven safety and rapid action for the treatment of diabetes in adults, adolescents and children.The positive opinion of the CHMP for the extension of its use in children from a year of age means that, once the European Commission approves this expansion of its indication, doctors will have a rapid trusted action insulin with which to treatThese children at meals. ”
The CHMP recommendation for the widespread use of Novorapid ® in children from a year of age is based on the pediatric tests Begin Young 1 and Boost T1D, which investigated the efficacy and safety of insulin Degludec and insulin Degludec/insulin aspart respectively.In both studies, the comparator was Insulina Detemir.
The results of the studies showed a similar glycemic control in regards to the reduction of HBA1C glycosylated hemoglobin both among the groups by type of treatment and among the groups by age.The data also showed that Novorapid ® was well tolerated in children and adolescents with type 1 diabetes, including those of one year old.
The positive opinion of the CHMP will be sent to the European Commission for its final regulatory decision, which is expected to occur in less than two months.
about novorapid ®
Novorapid ® (Insulina Aspart) is an analogous of fast action insulin that is managed before meals indicated for the treatment of diabetes mellitus in adults, adolescents and children from two years of age5.6.Novorapid® can be used during pregnancy.It has been available in Europe since 1999 and has been launched in more than 120 countries.