Otezla

apremilast

Table of contents

Opinion

On 27 February 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Otezla. The marketing authorisation holder for this medicinal product is Amgen Europe B.V.

The CHMP adopted a new indication as follows:

“Behçet’s disease

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.”

For information, the full indications for Otezla will be as follows:

“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 (see section 5.1).

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).

Behçet’s disease

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.”

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

Key facts

Name
Otezla
Agency product number
EMEA/H/C/003746
International non-proprietary name (INN) or common name
  • apremilast
Active substance
  • apremilast
Therapeutic area
Arthritis, Psoriatic
Psoriasis
Date opinion adopted
27/02/2020
Company name
Amgen Europe B.V.
Status
Positive
Application type
Post-authorisation

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