Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Remsima, 100 mg powder for concentrate for solution for infusion intended for the treatment of rheumatoid arthritis, adult Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
The active substance of Remsima is Infliximab, an immunosuppressant. Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNF-alpha but not to lymphotoxin-alpha ( TNF-beta ).
Remsima is a biological medicinal product similar to the reference product Remicade ( Infliximab ) authorised in the European Medicines ( EU ) since 13 August 1999. Studies have shown Remsima to have a comparable quality, safety and efficacy profile to Remicade.
The approved indications are:
Rheumatoid arthritis - Remsima, in combination with Methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease-modifying antirheumatic drugs ( DMARDs ), including Methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with Methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated.
Adult Crohn’s disease - Remsima is indicated for: treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies; treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment ( including antibiotics, drainage and immunosuppressive therapy ).
Paediatric Crohn’s disease - Remsima is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.
Ulcerative colitis - Remsima is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-Mercaptopurine ( 6-MP ) or Azathioprine ( AZA ), or who are intolerant to or have medical contraindications for such therapies.
Paediatric ulcerative colitis - Remsima is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Ankylosing spondylitis - Remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Psoriatic arthritis - Remsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Remsima should be administered: in combination with Methotrexate, or alone in patients who show intolerance to Methotrexate or for whom Methotrexate is contraindicated.
Infliximab 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.
Psoriasis - Remsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including Cyclosporine, Methotrexate or Psoralen ultra-violet A ( PUVA ).
It is proposed that Remsima be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis. Remsima is a medicinal product subject to restricted medical prescription. ( Xagena )
Source: EMA, 2013
XagenaMedicine_2013
