Regulatory Decision Summary for Panzyga
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.
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What was the purpose of this submission?
The purpose of this Supplemental New Drug Submission (SNDS) was to obtain approval for the extension of the indications of Panzyga (Immunoglobulin Intravenous [Human], 10%) in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). In support for the proposed indication, safety and efficacy data were provided from a prospective, double-blind, randomized, dose controlled multicenter Phase III study (Study NGAM-08).
Why was the decision issued?
The efficacy and safety of Panzyga in adults with CIDP was evaluated in the pivotal Study NGAM-08. The study was conducted in 25 study sites in Canada and Europe. One hundred forty-two (142) patients aged (18 to 83 years) entered the dose evaluation period and were randomized at a ratio of 1:2:1 to 0.5 g/kg, 1.0 g/kg or 2.0 g/kg Panzyga treatment groups, for 7 maintenance infusions at 3-week intervals. There were 35, 69 and 38 subjects in 0.5 g/kg, 1.0 g/kg or 2.0 g/kg Panzyga dose groups, respectively.
The objective was to determine the proportion of responders in the Panzyga treatment group receiving a dose of 1.0 g/kg. A responder was defined as a patient showing a decrease of at least 1 point in the Inflammatory Neuropathy Cause and Treatment (INCAT) disability score at the end of the study (24 weeks) relative to their baseline score. This primary efficacy endpoint was established in 79.7% of patients classified as responders in the 1.0 g/kg treatment group. Efficacy was also shown at 1.0 and 2.0 g/kg doses using the INCAT and various other disability measurements.
The most common adverse reactions observed during Study NGAM-08 included headache, fever, dermatitis and increase in blood pressure. There were are no new safety risk identified with the use of Panzyga for the treatment of CIDP, and current risk mitigations as described in the Product Monograph were deemed adequate. Taken together, Panzyga was shown to have a favorable benefit-risk profile for treatment of adult patients with CIDP.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations