Regulatory Decision Summary for Ziagen
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) is to expand the current indication for Ziagen to include once-daily treatment dosing with abacavir (in combination with other antiretroviral drugs) for pediatric patients aged 3 months and older.
Why was the decision issued?
Expanding the dosing frequency options for Ziagen to include once-daily dosing will provide greater flexibility and allow clinicians to tailor treatment regimens to fit with the patients and caregivers needs, align dosing schedules with other anti-retroviral therapies, and simplify treatment schedules, thereby increasing the opportunity for maximal treatment adherence. Furthermore, the alignment of the dosing weight bands with those of the World Health Organization (WHO), which involves minor revisions at 2 weight band thresholds in addition to harmonisation of Ziagen pediatric usage is intended to further simplify and clarify dosing for the patients, caregivers, and clinicians. In addition, this would remove the weight bands discrepancy between the prescribing information in Canada and WHO recommendations in endemic countries where there is a greater incidence of human immunodeficiency virus (HIV) infection in children.
No additional safety issues have been identified in paediatric subjects receiving either once- or twice-daily dosing compared to adults.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.