Wezenla (ustekinumab)
- Region
- 🇪🇺 EU
- Active substance
- ustekinumab
- Company
- Amgen Technology (Ireland) UC
- Status
- Authorised
- Therapeutic area
- Psoriasis; Arthritis, Psoriatic; Crohn Disease
- CHMP opinion
- Thu 25 Apr 2024
- EU approval
- Thu 20 Jun 2024
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006132
- ATC
- L04AC05
- Official record
- www.ema.europa.eu
Indication
Crohn’s diseaseWezenla is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Pediatric Crohn's diseaseWezenla is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.Plaque psoriasisWezenla is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).Paediatric plaque psoriasisWezenla is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).Psoriatic arthritis (PsA)Wezenla, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
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