Regulatory Decision Summary for Soliris
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.
Product type:
Medicinal ingredient(s):
Therapeutic area:
ATC code: L04AA25
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of this submission is to seek marketing authorization in Canada for Soliris (eculizumab) in adult patients with generalized Myasthenia Gravis.
Why was the decision issued?
The efficacy of Soliris in adult patients with gMG was demonstrated in the pivotal trial. Change from baseline at Week 26 relative to placebo for primary endpoint MG-ADL and key secondary endpoint QMG was statistically significant. The proportion of MG-ADL and QMG clinical responders at Week 26 was greater in the Soliris arm and was clinically significant.
The most common adverse reactions (ADR) that occurred in the Soliris-treated patients in the pivotal study include musculoskeletal pain, herpes simplex infection, peripheral edema, abdominal pain, contusion, and pyrexia. Additional most common ADRs (≥10%) that occurred in open-label extension study were headache, nasopharyngitis, diarrhea, arthralgia, upper respiratory tract infection, and nausea. Overall, the safety profile of eculizumab in the target patient population is acceptable.
The efficacy results are based on analyses that ignored the use of rescue medication and other efficacy-related protocol deviations. While such a context might reflect a real-world healthcare setting, results should be considered with this caveat in mind.
Overall, the benefits of Soliris outweigh its risks for the indication sought. The benefit/risk profile of Soliris is favourable in the target patient population.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.