Questions & Answers
On 15 December 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lifmior, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis. The applicant for this medicinal product is Pfizer Limited.
Lifmior will be available in 10 mg, 25 mg and 50 mg strengths either as a powder and solvent for a solution for injection or as a ready-made solution for injection. The active substance of Lifmior is etanercept, a tumour necrosis factor alpha (TNF-α) inhibitor (ATC code: L04AB01).
TNF is a cytokine involved in inflammatory processes. The mechanism of action of etanercept is thought to be the competitive inhibition of TNF binding to cell surface TNF receptors, which prevents TNF-mediated cellular responses and renders TNF biologically inactive.
Lifmior is an identical product to Enbrel, which has been authorised in the EU since 3 February 2000.
The full indication is:
Lifmior 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.
Lifmior can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Lifmior is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Lifmior, 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.
Lifmior 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. Lifmior 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 nonsteroidal 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.”
Lifmior treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non‑radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
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 Lifmior||(English only)||2016-12-16|
|INN or common name|
|Therapeutic area||Spondylitis, AnkylosingArthritis, PsoriaticPsoriasis|
|Date opinion adopted||15/12/2016|
|Application type||Initial authorisation|
More infomration on Lifmior
- Questions and answers on generic medicines (2012-12-07)