CHMP Meeting Highlights June 2021

messages in brief | 07/07/2021

Information about the Austrian representation on the CHMP and monthly updates can be found at this link.

This month, medicinal products for the following indications have received a positive opinion:

  • Achondroplasia
  • Anaemia in Patients with Chronic Kidney Disease
  • Choroidal Neovascularisation
  • Diabetic Retinopathy
  • Diffuse Large B‑cell Lymphoma (DLBCL)
  • Macular Degeneration
  • Macular Oedema Secondary to Retinal Vein Occlusion
  • Multiple Myeloma
  • Plaque Psoriasis

New medicines recommended for approval:

Abecma (idecabtagene vicleucel): received a positive opinion for a conditional marketing authorisation based on an assessment by EMA’s Committee for Advanced Therapies (CAT), for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least three previous therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment. MM is a blood cancer characterized by the malignant proliferation of plasma cells which consistently express the B-cell maturation antigen (BCMA). BCMA is not expressed in normal non-hematopoietic cells. Abecma is a gene therapy product that consists of modified autologous T cells which, upon activation, trigger the cytolytic death of cells that express BCMA. For more information please consult the product page for Abecma on the EMA website.

Bimzelx: (bimekizumab): for the treatment of moderate to severe plaque psoriasis. Psoriasis is a common chronic inflammatory skin disease with different clinical phenotypes with 80 to 90 % of patients being affected by plaque psoriasis. Raised, sharply demarcated, erythematous plaques covered by silvery scales characterize plaque psoriasis. Bimzelx is a monoclonal antibody, which reduces the body’s inflammatory response by neutralising several cytokines. For more information please consult the product page for Bimzelx on the EMA website.

Byooviz (ranibizumab): for the treatment of

  • Neovascular (wet) age-related macular degeneration,
  • Visual impairment due to diabetic macular oedema,
  • Proliferative diabetic retinopathy,
  • Visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO),
  • Visual impairment due to choroidal neovascularisation.

Vascular endothelial growth factor A (VEGF-A) is the main protein responsible for the induction of blood vessel growth and, therefore, it is thought to contribute to the pathophysiology of diseases that involve blood vessels, such as the ones included in the indication. Byooviz is a monoclonal antibody, which inhibits the VEGF-A pathway by blocking the binding to its receptor.  Byooviz is a similar biological medicinal product to Lucentis. For more information please consult the product page for Byooviz on the EMA website.

Evrenzo (roxadustat): for the treatment of anaemia symptoms in patients with chronic kidney disease (CKD). Several factors can contribute to the development of anaemia in patients with CKD, including insufficient production of erythropoietin, impaired iron absorption, shorter lifespan of red blood cells or blood loss associated with haemodialysis. Evrenzo inhibits the hypoxia-inducible factor (HIF) prolyl hydroxylase, thereby stabilizing HIFs’ alpha subunit (HIF-α). The HIF transcription factors subsequently induce the expression of erythropoietin. For more information please consult the product page for Evrenzo on the EMA website.

Minjuvi (tafasitamab): received a positive opinion for a conditional marketing authorisation for the treatment of adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) who are not eligible for autologous stem-cell transplant (ASCT). DLBCL is an aggressive cancer of the B-lymphocytes and it is the most common form of non-Hodgkin lymphoma. Minjuvi is a monoclonal antibody, which binds to the CD19 surface antigen of B-cells, leading to antibody-dependent cell death. For more information please consult the product page for Minjuvi on the EMA website.

Voxzogo (vosoritide): for the treatment of achondroplasia in patients two years of age and above whose epiphyses are not closed. Achondroplasia is a genetic disease caused by mutations in the fibroblast growth factor receptor 3 gene (fgfr3), which result in the expression of an overactive protein that interferes with chondrocytic bone growth. Therefore, patients with achondroplasia display dwarfism as a primary feature. Voxzogo is a recombinant C-type natriuretic peptide (CNP), which counteracts the downstream effects of the overactive FGFR3 by activating the natriuretic peptide receptor type B (NPR-B). For more information please consult the product page for Voxzogo on the EMA website.

Recommendations on extensions of therapeutic indication:

Edistride (dapagliflozin): extension of indication to include the treatment in adults of chronic kidney disease. Edistride had previously been authorised for the treatment of type 2 diabetes mellitus and heart failure. For more information please consult the product page for Edistride on the EMA website.

Forxiga (dapagliflozin): extension of indication to include the treatment in adults of chronic kidney disease. Forxiga had previously been authorised for the treatment of type 1 and 2 diabetes mellitus and heart failure. For more information please consult the product page for Forxiga on the EMA website.

Galafold (migalastat): extension of indication to include the treatment of adolescents aged 12 years and older. For more information please consult the product page for Galafold on the EMA website.

Opdivo (nivolumab): extension of indication to include, as monotherapy, the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. Opdivo had previously been authorised, in combination or as monotherapy, for the treatment of melanoma, non-small cell lung cancer (NSCLC), malignant pleural mesothelioma (MPM), renal cell carcinoma (RCC), classical Hodgkin lymphoma (cHL), squamous cell cancer of the head and neck (SCCHN), urothelial carcinoma, oesophageal squamous cell carcinoma (OSCC) and colorectal cancer. For more information please consult the product page for Opdivo on the EMA website.

Rinvoq (upadacitinib): extension of indication to include the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Rinvoq had previously been authorised for the treatment of rheumatoid and psoriatic arthritis, and ankylosing spondylitis. For more information please consult the product page for Rinvoq on the EMA website.

Xeljanz (tofacitinib): extension of indication to include the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive or negative polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs. Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Xeljanz had previously been authorised for the treatment of rheumatoid and psoriatic arthritis, and ulcerative colitis. For more information please consult the product page for Xeljanz on the EMA website.

Newly published EPARs

The EPAR (European public assessment report) is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP. Below is a list of the EPARs for recently approved products that have been made available at the EMA homepage between May 21 - June 24, 2021:

Copiktra (duvelisib): for the treatment of chronic lymphocytic leukaemia (CLL). EPAR Copiktra.

Nexpovio (selinexor): for the treatment of multiple myeloma. EPAR Nexpovio.

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