Otezla (apremilast)
- Region
- 🇪🇺 EU
- Active substance
- apremilast
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Arthritis, Psoriatic; Psoriasis; Behcet Syndrome
- EU approval
- Thu 15 Jan 2015
- Application
- EMEA/H/C/003746
- ATC
- L04AA32
- Official record
- www.ema.europa.eu
Indication
Psoriatic arthritisOtezla, 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. PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis (PSOR) 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). Paediatric psoriasisOtezla is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years and weighing at least 20 kg who are candidates for systemic therapy.Behçet’s diseaseOtezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Apremilast Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Apremilast Viatris Application withdrawn · Viatris Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.