Regulatory Decision Summary for REVESTIVE

The efficacy and safety of REVESTIVE were evaluated in two 24-week Phase III controlled studies, each followed by a 2-year open-label extension study. The results obtained from these clinical trials showed, that the treatment with REVESTIVE reduces the parenteral support by at least 20% in patients with SBS, and at least one day reduction in parenteral support in some patients.

REVESTIVE is supplied as powder for solution for injection, 5 mg/vial. The recommended daily dose of REVESTIVE is 0.05 mg/kg body weight administered by subcutaneous injection once daily.

REVESTIVE should not be used in patients who have active gastrointestinal malignancy or a history of such conditions in the last 5 years. Treatment should be initiated under the supervision of a medical professional with experience in the treatment of SBS.

The safety profile of REVESTIVE, a new-in-class drug, is acceptable for the target population and disease treated. In order to ensure that this benefit continues to outweigh any risk after authorization, Health Canada has required several post-approval activities to be carried out and a Risk Management Plan.

For more information on Health Canadas decision, please view the Summary Basis of Decision.