Questions & Answers
On 21 April 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Erelzi, intended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis. The applicant for this medicinal product is Sandoz GmbH.
Erelzi will be available as a solution for injection (25 mg and 50 mg). The active substance of Erelzi is etanercept, a tumour necrosis factor alpha (TNF‑α) inhibitor (ATC code: L04AB01). The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF mediated cellular responses by rendering TNF biologically inactive. Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
Erelzi is a biological medicinal product that is highly similar to the reference product Enbrel (etanercept), which was authorised in the EU on 3 February 2000. Studies have shown that Erelzi has comparable quality, safety and efficacy to Enbrel.
The full indication is:
Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease‑modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X‑ray and to improve physical function.
Juvenile idiopathic arthritis
Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Treatment of enthesitis‑related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Etanercept has not been studied in children aged less than 2 years.
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease‑modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X‑ray in patients with polyarticular symmetrical subtypes of the disease.
Ankylosing spondylitis (AS)
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Non‑radiographic axial spondyloarthritis
Treatment of adults with severe non‑radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C‑reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non‑steroidal anti‑inflammatory drugs (NSAIDs).
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet‑A light (PUVA) (see section 5.1).
Paediatric plaque psoriasis
Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.”
It is proposed that Erelzi should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of the diseases Erelzi is used to treat.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
|Name||Language||First published||Last updated|
|CHMP summary of positive opinion for Erelzi||(English only)||2017-04-21|
|INN or common name|
|Therapeutic area||Spondylitis, AnkylosingArthritis, RheumatoidArthritis, PsoriaticPsoriasisArthritis, Juvenile Rheumatoid|
|Date opinion adopted||21/04/2017|
|Application type||Initial authorisation|