Regulatory Decision Summary for Lemtrada
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:
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of this Supplementary New Drug Submission (SNDS) was to seek a market authorisation for an additional course of 12 mg/day for 3 days (36 mg total dose) of alemtuzumab on an as-needed basis and updating the long-term efficacy and safety claims. No changes to the wording of the indication were originally proposed by the sponsor in this SNDS.
Because of safety issues that have been observed recently post-market, Health Canada revised the indication to restrict the use of Lemtrada:
"Lemtrada (alemtuzumab) is indicated for the management of adult patients with relapsing remitting multiple sclerosis (RRMS), with highly active disease defined by clinical and imaging features, despite an adequate course of treatment with at least two other disease modifying treatments (DMTs), or where any other DMT is contraindicated or otherwise unsuitable with the recommended dose 12 mg/day administered by intravenous (IV) infusion for 2 treatment courses."
Why was the decision issued?
The current SNDS proposed an additional treatment option on as-needed basis, based on a phase 3, multicenter, open-label, rater-blinded, efficacy and safety extension study.
Review of the data identified a number of important limitations and sources of bias that precluded a meaningful interpretation of the long-term efficacy data and results.
Importantly, new risks were recently observed post-market, including hepatic injuries, immune-mediated disorders, and serious cardiovascular reactions. The PM was updated accordingly, including the addition of these risks to the Serious Warnings and Precautions Box and cross-references to the relevant sections.
As part of risk mitigation strategies, the indication of use was revised to reflect a more selective patient population who did not adequately respond to other therapies.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations as per the Notice of Compliance with Conditions Guidance.