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LEVEMIR (insulin detemir), long-acting human insulin analogue
DIABETOLOGY - New indication
Opinions on drugs -
Posted on
Mar 03 2017
Reason for request
Extension of indication
No actual benefit demonstrated relative to TRESIBA in the management of type 1 diabetes in children aged 1 to 2 years.
- LEVEMIR has Marketing Authorisation in type 1 diabetes in children aged 1 year.
- The available clinical efficacy data in children between age 1 and 2 years are limited to a non-inferiority study versus insulin degludec conducted on 350 children with type 1 diabetes aged between 1 and 17 years, of which only 4 were aged 1 to 2 years.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
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