Summary of Cancellation for diroximel fumarate (*Vumerity)
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.
Product type:
Medicinal ingredient(s):
diroximel fumarate
Therapeutic area:
Immunosuppressants
Type of submission:
New Drug Submission (New Active Substance)
Control number:
240071
Decision issued:
No decision was issued by Health Canada. The company chose to cancel its submission before a final decision was issued.
Date of Cancellation:
2023-02-28
What was the purpose of this submission?
The purpose of this submission was to gain regulatory approval for the claim that diroximel fumarate represents a novel oral therapy for the treatment of relapsing-remitting multiple sclerosis, with similar efficacy and safety to dimethyl fumarate, and a more favorable gastrointestinal tolerability profile.
What did the company submit to support its submission?
The New Drug Submission for diroximel fumarate (DRF) relied on the efficacy and in part on the prior findings of safety for the Health Canada authorized drug, Tecfidera (dimethyl fumarate [DMF]). Such reliance was supported by a pharmacokinetic (PK) bridging approach that was designed to test whether exposure of monomethyl fumarate (MMF), the common active metabolite, after administering DRF and DMF orally as 462 milligrams (mg) and 240 mg, respectively, was bioequivalent. This PK approach was further supported by a comprehensive nonclinical and clinical program to qualify and characterize DRF and its metabolites, along with long-term safety data for DRF.
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
At the time of the cancellation, Health Canada was assessing the Response to Notice of Deficiency (NOD) issued on April 20, 2021. Health Canada had identified some deficiencies in the pivotal fasting and fed comparative bioavailability studies. The sponsor chose to cancel their submission before a decision was issued.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact for patients using SAP or in clinical trials.
*Proposed Brand Name:
Vumerity
Manufacturer:
Biogen Canada Inc.
Drug Identification Numbers issued:
N/A
Date filed:
2020-05-29