Regulatory Decision Summary for Vimpat
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?
Vimpat is currently approved for adjunctive therapy in the management of partial-onset seizures in adult patients with epilepsy who are not satisfactorily controlled with conventional therapy. The purpose of the current submission was to add monotherapy treatment to the indication.
Why was the decision issued?
The majority of patients with epilepsy rely on adjunctive treatment (>1 antiepileptic drug [AED]) to control their attacks. Most AEDs that are currently marketed in Canada are indicated for adjunctive therapy. Although the ideal goal is to achieve seizure-free status, drastic reduction of frequency of attacks remains the principal objective. Therefore, there is room for improvement in the quality of therapy and new drugs that provide better efficacy with improved adverse event profile.
Polytherapy has been reported to be the standard of care in epilepsy and has long been given as initial treatment. More recently, data indicate that a large number of patients given initial monotherapy remained seizure-free for as long as one year. There is no doubt that the odds of better tolerability and improved safety improve when a patient is treated with one drug instead of a combination of products each of which can impose a set of adverse events and may also interact with one another. Thus, it would be ideal to either convert patients from polytherapy to monotherapy and/or attempt to treat patients that are newly or recently diagnosed with epilepsy, with a single AED.
This submission consisted of Study SP0993, a positive-controlled (carbamazepine controlled release: CBZ-CR), non-inferiority trial which tested the safety and efficacy of lacosamide (LCM) doses 200 to 600 mg/day in patients with newly or recently diagnosed epilepsy. Data from Study SP0993 showed that LCM (200 to 600 mg/day) was non-inferior to CBZ-CR (400 to 1200 mg/day) in terms of efficacy. Safety data from Study SP0993 demonstrated a similar adverse event profile as that of LCM when used as adjunctive treatment. Overall, longer term treatment with daily doses of LCM 200 to 600 mg, administered as monotherapy in patients newly or recently diagnosed with epilepsy (Study SP0994), appeared to produce a similar safety profile to that of Study SP0993. All other safety issues currently known to Health Canada have also been labeled properly.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations