Question 56

Can risk data be presented for patients with concomitant risk factors. ie, the product is a statin that is indicated to reduce cholesterol and also CV events in patients with high cholesterol. The registration trial obviously included patients with high cholesterol and other risk factors. Can risk data be presented on patients with hypercholesterolemia and a risk factor within the registration trial?
The PAAB Code section 3.1 clearly states that all claims must be consistent with the Health Canada approved Terms of Market Authorization (TMA) (e.g. product monograph). The US FDA approved PI would not meet that requirement. The TMA does contain a section referring to pharmacokinetics data and PAAB would look at that section for support.

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