Dimethyl fumarate Accord

Opinion

EMA has issued an opinion on this medicine

dimethyl fumarate

Overview

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dimethyl fumarate Accord, intended for the treatment of multiple sclerosis. The applicant for this medicinal product is Accord Healthcare.

Dimethyl fumarate Accord will be available as 120 mg and 240 mg gastro-resistant hard capsules. The active substance of Dimethyl fumarate Accord is dimethyl fumarate, an immunosuppressant (ATC code: L04AX07). Dimethyl fumarate acts primarily by activating the Nrf2 transcriptional pathway, which reduces inflammation and modulates the activity of immune cells, thereby protecting the cells of the central nervous system from damage.

Dimethyl fumarate Accord is a generic of Tecfidera, which has been authorised in the EU since 30 January 2014. Studies have demonstrated the satisfactory quality of Dimethyl fumarate Accord and its bioequivalence to the reference product Tecfidera. A question and answer document on generic medicines can be found here.

The full indication is:

Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Treatment should be initiated under the supervision of a physician experienced in the treatment of multiple sclerosis.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Dimethyl fumarate Accord

AdoptedReference Number: EMA/CHMP/107040/2024

Product details

• Name of medicine:
  Dimethyl fumarate Accord
• Active substance:
  dimethyl fumarate
• International non-proprietary name (INN) or common name:
  dimethyl fumarate
• Therapeutic area (MeSH):
  Multiple Sclerosis
• Anatomical therapeutic chemical (ATC) code:
  L04AX07
• EMA product number:
  EMEA/H/C/006471
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation applicant:
  Accord Healthcare Ltd
• Opinion adopted:
  21/03/2024
• Opinion status:
  Positive