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REVESTIVE (teduglutide), synthetic GLP-2 analogue
GASTROENTEROLOGY-New indication
Opinions on drugs -
Posted on
Jun 29 2017
Reason for request
Extension of indication
Moderate improvement in the treatment of children > one year, and adolescents with short bowel syndrome who have been receiving parenteral nutrition for several months.
- REVESTIVE has now Marketing Authorisation in the treatment of short bowel syndrome in children > one year and adolescents. Patients must be stable following a period of intestinal adaptation after surgery.
- A reduction in parenteral nutrition needs, allowing withdrawal for some patients, has been observed at 12 weeks. The level of evidence of the demonstration of efficacy is low.
- There are no long-term efficacy and safety data, but there is no therapeutic alternative, so the unmet medical need is substantial.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| moderate |
- |
Therapeutic use
|
- |
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