Apremilast Accord (apremilast)
- Region
- 🇪🇺 EU
- Active substance
- apremilast
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Arthritis, Psoriatic; Psoriasis; Behcet Syndrome; Oral Ulcer
- CHMP opinion
- Thu 22 Feb 2024
- EU approval
- Fri 19 Apr 2024
- Designations
- Generic
- Application
- EMEA/H/C/006208
- ATC
- L04AA32
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Otezla Authorised · Amgen Europe B.V.
- 🇪🇺 Apremilast Viatris Application withdrawn · Viatris Limited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.