Sotyktu - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation
deucravacitinib
Post-authorisationHuman
On 26 March 2026, 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 Sotyktu. The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
The CHMP adopted a new indication as follows:
Plaque psoriasis
Sotyktu is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Psoriatic arthritis
Sotyktu, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy (see section 5.1).
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Notes: New text in bold
CHMP post-authorisation summary of positive opinion for Sotyktu (VR/0000282554)
Adopted
Reference Number: EMADOC-1700519818-2802747
English (EN) (123.5 KB - PDF)
First published: