Diroximel fumarate for treating relapsing-remitting multiple sclerosis

Diroximel fumarate for treating relapsing-remitting multiple sclerosis

• NICE state that:
  • diroximel fumarate is recommended as an option for treating active relapsing-remitting multiple sclerosis (normally defined as 2 clinically significant relapses in the previous 2 years) in adults, only if:
    • they do not have highly active or rapidly evolving severe relapsing-remitting multiple sclerosis and
    • the company provides diroximel fumarate according to the commercial arrangement
  • the NICE committee states ".. diroximel fumarate is expected to be as clinically effective as dimethyl fumarate, which NICE already recommends for active relapsing–remitting multiple sclerosis. Clinical trial evidence suggests that diroximel fumarate causes fewer gastrointestinal side effects than dimethyl fumarate..."
    
    
• diroximel fumarate (DRF) is an oral fumarate for the treatment of relapsing forms of MS, administered as a maintenance dose of two 231-mg capsules twice daily
  • following oral administration, DRF is metabolized to monomethyl fumarate, the same pharmacologically active metabolite as dimethyl fumarate (DMF) and, therefore, the overall safety and efficacy profiles of DRF and DMF are expected to be similar (1,2)
    
    
  • DMF
    • has demonstrated a favorable benefit-risk profile in clinical studies of patients with relapsing-remitting MS
    • note though that some patients taking DMF experience gastrointestinal (GI) adverse events (AEs) early in treatment that may lead to dose interruption or discontinuation
      
      
  • in comparison to DMF
    • DRF has a distinct chemical structure and a higher molecular weight that is hypothesized to produce less GI irritation in the GI tract and improve GI tolerability due to less reactivity with off-target proteins

Reference:

• NICE (June 2022). Diroximel fumarate for treating relapsing-remitting multiple sclerosis.
• Liseno J, Lager B, Miller C, Shankar SL, Mendoza JP, Lewin JB. Multiple Sclerosis Patients Treated With Diroximel Fumarate in the Real-World Setting Have High Rates of Persistence and Adherence. Neurol Ther. 2021;10(1):349-360. doi:10.1007/s40120-021-00242-7