Basic Information
Otezla
Regulatory Information
EMEA/H/C/003746
January 15, 2015
23
October 22, 2024
Company Information
the netherlands
Minervum 7061 4817ZK Breda
Amgen Europe BV
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication **Psoriatic arthritis** Otezla, 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. **Psoriasis** Otezla 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).
Overview Summary
Otezla 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). Otezla 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. Otezla contains the active substance apremilast.