Regulatory Decision Summary for Radicava
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.
Type of submission:
What was the purpose of this submission?
Mitsubishi Tanabe Pharma Corporation submitted a New Drug Submission to gain approval of Radicava (edaravone) for treatment of amyotrophic lateral sclerosis.
Why was the decision issued?
Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease with a median survival time of 3 years after onset of symptoms, and consequently, there is an urgent unmet medical need for ALS therapies. Edaravone has been shown to be effective at slowing the decline of function in daily activities in ALS. Although edaravone demonstrated efficacy in early stages of ALS, distinguishing between early and later stage ALS can sometimes be challenging due to the heterogeneity among individuals in the rate at which ALS symptoms progress. Further, a 6-month open-label phase in the pivotal trial supported meaningful clinical effects in later stage ALS. For these reasons, the indication for edaravone was not limited to early stage ALS patients.
No major safety signal was identified during the clinical trials. The majority of subjects in the edaravone program reported adverse events, but many of these represented worsening of their disease, and the frequency of serious adverse events was low and generally comparable between placebo and edaravone groups. Cases of hypersensitivity and anaphylaxis have been reported with edaravone post-marketing and this risk is described in the proposed Product Monograph. Thus, the safety profile of edaravone is acceptable, and the overall benefit-risk balance of edaravone for treatment of ALS is considered positive.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.