Basic Information
Apremilast Accord
Regulatory Information
EMEA/H/C/006208
April 19, 2024
February 22, 2024
May 21, 2024
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Psoriatic arthritis Apremilast Accord, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1). Psoriasis Apremilast Accord is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). Behçet’s disease Apremilast Accord is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.
Overview Summary
Apremilast Accord is a medicine used to treat adults with: • moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin). It is used in patients who have not responded to or cannot use other systemic (affecting the whole body) treatments for psoriasis, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A). PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen’ before being exposed to ultraviolet light; • active psoriatic arthritis (inflammation of the joints associated with psoriasis) in patients who cannot take or who have not responded well enough to other treatments called disease-modifying antirheumatic drugs (DMARDs). Apremilast Accord may be used alone or combined with other DMARDs; • ulcers in the mouth caused by Behçet’s disease, an inflammatory disease that may affect many parts of the body. Apremilast Accord is a ‘generic medicine’. This means that Apremilast Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Apremilast Accord is Otezla. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf). Apremilast Accord contains the active substance apremilast.