EU Panel Endorses Approval for Insulin Degludec in Children

Miriam E Tucker


December 22, 2014

A European Union panel has endorsed approval for the use of insulin degludec (Tresiba, Novo Nordisk) in adolescents and children down to 1 year of age.

The Committee for Medicinal Products for Human Use of the European Medicines Agency issued the positive opinion on December 19 for the change to the terms of the marketing authorization.

Insulin degludec is a long-acting, once-daily insulin that forms soluble multihexamers on subcutaneous injection. It has a half-life of 25 hours, which is twice as long as the half-life of currently available basal insulin products, with a 42-hour duration of effect.

Insulin degludec was first approved for use in adults in the European Union in January 2013.

Results of a trial showing that Tresiba is effective and safe for long-term use in children and young adults with type 1 diabetes were presented at the European Association for the Study of Diabetes meeting in September.

Although Novo Nordisk currently holds an almost 50% share of the insulin drug market worldwide, it faces challenges, in part because the US Food and Drug Administration (FDA) has rejected insulin degludec; the product is seen as an important future growth driver.

The FDA turned Tresiba down in February 2013, requesting additional cardiovascular-outcomes data, despite an endorsement from its endocrinologic drug advisory panel in November 2012.

"Additional data required by the US FDA are being generated for the planned resubmission," according to Novo-Nordisk's website.


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