Regulatory Decision Summary for STRENSIQ

The efficacy and safety of STRENSIQ (asfotase alfa) was evaluated in several clinical trials. Most of these clinical trials are still ongoing. The preliminary data obtained from these trials showed a promising effect of STRENSIQ in improving radiographic evidences of healing of rickets, bone histomorphology and growth in hypophosphatasia, considered as a rare disease.

STRENSIQ (asfotase alfa) is supplied as a solution for subcutaneous injection. The recommended dosage regimen of STRENSIQ is 2 mg/kg of body weight administered subcutaneously three times per week, or a dosage regimen of 1 mg/kg of body weight administered six times per week.

The safety profile of STRENSIQ (asfotase alfa) was found to be acceptable for STRENSIQ which is intended to be used as enzyme replacement for this rare disease. Therefore, the overall Benefit/Risk of STRENSIQ (asfotase alfa) is considered acceptable, to date, for the proposed indication. Further follow-up to verify the clinical benefit has been required by Health Canada.

Therefore a Notice of Compliance with Conditions (NOC/c) is issued for STRENSIQ for the indication note above, until additional information becomes available. A Risk Management Plan has also been required by Health Canada in order to ensure that the promising benefits of STRENSIQ continue to outweigh the risks in the longer term.

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