REVESTIVE (teduglutide) - Short bowel syndrome (SBS)

The Committee deems that the clinical benefit of REVESTIVE 1.25 mg and 5 mg (teduglutide) remains substantial in the MA indication.

Considering:

• the efficacy results from new clinical studies, including some conducted in routine clinical practice in France, with a low level of evidence but consistent with the data previously assessed, with an efficacy of REVESTIVE (teduglutide) in terms of reduction in parenteral nutrition volume, making it possible to reduce parenteral nutrition by one day per week on average, and hence a benefit with regard to patients’ quality of life,
• withdrawal of parenteral nutrition observed in a few patients treated with teduglutide,
• the absence of an established impact on morbidity and mortality,
• the safety profile of teduglutide (frequent but non-severe adverse effects) and the need to monitor patients treated with teduglutide (for endoscopic detection, of polyps in particular),

the Committee considers that REVESTIVE 1.25 mg and 5 mg (teduglutide) provides a minor clinical added value (level IV)  in adult patients with short bowel syndrome (SBS) receiving parenteral nutrition (PN) for several months and when the adaptation and compensatory hyperphagia options do not permit withdrawal of parenteral nutrition.