Cosentyx - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

secukinumab

Opinion

On 17 September 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 Cosentyx. The marketing authorisation holder for this medicinal product is Novartis Europharm Limited.

The CHMP adopted a new indication as follows:

Polymyalgia rheumatica (PMR)

Cosentyx is indicated for the treatment of polymyalgia rheumatica in adults who have had an inadequate response to glucocorticoids or who experience a relapse during glucocorticoid taper.

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

Adult plaque psoriasis

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Paediatric plaque psoriasis

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.

Hidradenitis suppurativa (HS)

Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy (see section 5.1).

Psoriatic arthritis

Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).

Axial spondyloarthritis (axSpA)

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)

Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.

Non-radiographic axial spondyloarthritis (nr-axSpA)

Cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (NSAIDs).

Juvenile idiopathic arthritis (JIA)

Enthesitis-related arthritis (ERA)

Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy (see section 5.1).

Juvenile psoriatic arthritis (JPsA)

Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy (see section 5.1).

Polymyalgia rheumatica (PMR)

Cosentyx is indicated for the treatment of polymyalgia rheumatica in adults who have had an inadequate response to glucocorticoids or who experience a relapse during glucocorticoid taper.

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.

CHMP post-authorisation summary of positive opinion for Cosentyx (VR-0000326984)

Adopted Reference Number: EMADOC-1700519818-3220507

Key facts

• Name of medicine:
  Cosentyx
• EMA product number:
  EMEA/H/C/003729
• Active substance:
  secukinumab
• International non-proprietary name (INN) or common name:
  secukinumab
• Therapeutic area (MeSH):
  • Arthritis, Psoriatic
  • Psoriasis
  • Spondylitis, Ankylosing
• Anatomical therapeutical chemical (ATC) code:
  L04AC10
• Marketing authorisation holder:
  Novartis Europharm Limited
• Status:
  Positive