Regulatory Decision Summary for Fycompa
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?
Fycompa (perampanel) is currently approved in Canada as adjunctive therapy for the treatment of partial-onset seizures (POS) and primary generalized tonic-clonic (PGTC) seizures in adults. This Supplement to a New Drug Submission (SNDS) was submitted to seek the expansion of existing indications to include adolescents (12-17 years of age). To support this claim, the sponsor provided a number of pooling analyses of previously submitted studies which included some adolescent patients, a controlled regional study of adults and adolescents, and long-term safety data from extension studies. However, there is no specific, dedicated, controlled study in adolescents with a seizure-related end-point as the primary efficacy outcome.
Why was the decision issued?
The primary data provided in this submission to expand the indications to adolescents (12-17 years of age) was a pooled analysis of approximately 90 adolescent patients who participated in the 3 core studies that supported the initial registration of the product. The sponsor has also provided a new controlled study with an additional 62 adolescent patients exposed to permapanel doses of 4-12 mg/day, and two other completed extension studies with approximately 135 adolescent patients exposed to various perampanel doses for more than 1 year. Thus, there is ample safety data, including long-term exposure data to perampanel therapy in adolescents.
The pooled efficacy data demonstrated statistically and clinically meaningful decreases in seizures in the adolescent population that was comparable to the efficacy in the adult population.
Fycompa has a boxed warning for the risk of neuropsychiatric adverse events such as aggression, irritability, and hostility. In some instances, the frequency of these events appears to be slightly higher in adolescent patients compared to adults. This information has been added to the Warnings and Precautions as well as the Adverse Events sections of the Product Monograph. Post-marketing data available from the United States and Europe support the similarity of the safety profile of Fycompa in adolescents compared to adults.
The risks of Fycompa in adolescents are considered acceptable as they are mitigated by adequate medical and parental supervision. All patients with epilepsy, especially those below the age of 18 years, are under strict supervision of a specialist who also determines the appropriate combination therapies and prescribes the medications. This supervision includes initiation and up-titration to an ideal maintenance dose, plus regular visits to the clinic, which allow for frequent evaluation of the efficacy and safety of the product.
Given the efficacy observed and the close supervision of treatments by specialists in this field, the Benefit-Harm Uncertainty of Fycompa use in the treatment of adolescent patients with POS and/or PGTCs is favourable.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.