Regulatory Decision Summary for Revestive
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
Short bowel syndrome (SBS) is a rare and serious disease characterized by the inability to meet nutritional and fluid requirements on a conventional diet. Patients with SBS may therefore be dependent on nutritional support given by intravenous administration (parenteral support). The active substance in Revestive is teduglutide, a Glucagon-like peptide-2 (GLP-2) analog that is intended to promote greater reabsorption of nutrients in the gastrointestinal system.
Revestive (teduglutide for injection) is currently authorized for the treatment of adults with SBS who are dependent on parenteral support. This submission presented clinical information to support expanding the indication to pediatric patients 1 year of age and above with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
Why was the decision issued?
- The submission included two trials in 87 pediatric patients aged 1-17 years with Short Bowel Syndrome (SBS) and dependent on parenteral support. In the pivotal efficacy trial, 26 pediatric SBS patients received 0.05 mg/kg/day Revestive injected subcutaneously for a period of 24 weeks.
- The primary efficacy endpoint was the proportion of patients that achieved a 20% or greater reduction in weight-adjusted weekly parenteral support volume from baseline at the end of the trial. In the 24-week trial there were 69.2% of patients that achieved this endpoint.
- The safety profile in pediatric patients was largely consistent with the profile in adults. The most common adverse events experienced by pediatric patients treated with 0.05 mg/kg Revestive were pyrexia (fever), cough, abdominal pain, device-related infection, and headache.
- The recommended dose of the drug is 0.05 mg/kg/day injected subcutaneously in both adults and pediatric patients aged 1 year and above.
- Health Canada granted this submission a priority review based on Revestive being used for a rare disease for which other pharmacologic therapies are not available.
- Based on the totality of the evidence submitted in support of Revestive for the treatment of pediatric SBS patients who are dependent on PS, the benefit-risk profile is positive. There were clinically meaningful reductions in the amount of PS required and the risks associated with treatment are manageable with labelling and standard risk management activities.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.