Regulatory Decision Summary for KamRAB
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.
Type of submission:
What was the purpose of this submission?
The purpose of this submission was to seek market authorization for KamRAB, a human rabies immunoglobulin (HRIG) indicated for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal and in combination with a course of rabies vaccine.
After evaluation of the submitted data package, Health Canada authorized KamRAB for the following indication:
KamRAB is a human rabies immunoglobulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. KamRAB should be administered concurrently with a full course of rabies vaccine.
- Do not administer additional (repeat) doses of KamRAB once vaccine treatment has been initiated, since this may interfere with the immune response to the rabies vaccine.
- Do not administer KamRAB to patients with a history of a complete pre-exposure or post-exposure vaccination regimen and confirmed adequate rabies antibody titer.
Why was the decision issued?
The authorization of KamRAB was based on the results of three clinical studies that enrolled 160 healthy volunteers. In the first study, the sponsor sought to demonstrate that KamRAB is bioequivalent to BayRAB (a HRIG marketed in Israel). The second study assessed the inhibitory effect of KamRAB on active rabies antibody production following immunization with a rabies vaccine (Rabipur). The third and final study combined elements from the two first trials to demonstrate the efficacy of KamRAB in combination with a rabies vaccine (RabAvert) for post- exposure prophylaxis. The last trial compared the antibody response to KamRAB and RabAvert with that of HyperRAB and RabAvert.
The frequency of adverse events (AE) was balanced across the different treatment groups in clinical studies. The most common (AEs) in the KamRAB and Comparator HRIG groups were similar, and included injection-site pain (33% and 31% of subjects, respectively), headache (15% and 13% of subjects, respectively), myalgia (9% and 7% of subjects, respectively), and upper respiratory tract infection (9% and 10% of subjects, respectively). The most common (AEs) occurring within 72 hours of first injection in both treatment groups were similar to the most common AEs overall.
Some uncertainty remains with regards to the safety and efficacy of KamRAB for geriatrics, pediatrics, pregnant and breastfeeding patients among others. These limitations of data have been adequately mitigated through labelling. Therefore, the overall benefit-risk assessment is favourable.
The recommended dose is a single intramuscular (IM) injection at the dose of 20 IU per kilogram of body weight in combination of rabies vaccines. See the Product Monograph for details.
A Risk Management Plan (RMP) was also submitted and reviewed, finding that the proposed pharmacovigilance activities and routine risk minimization activities are considered sufficient at this time and the RMP is acceptable for use in the Canadian medical setting.
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.