Label extensions recommended by EMA/CHMP

23 September 2019

As well as recommending approval of four novel medicines and three generic medicines at its September 2019 meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced positive opinions for a number of label extensions, as follows:

Merck KGaA(MRK: DE) and Pfizer's (NYSE: PFE) anti-PD-L1 antibody Bavencio (avelumab) in combination with the tyrosine kinase inhibitor Inlyta (axitinib) for the first-line treatment of adults with advanced renal cell carcinoma.
GlaxoSmithKline's (LSE: GSK) intravenous formulation of Benlysta (belimumab as an add-on therapy in children aged five years and older with active, autoantibody-positive systemic lupus erythematous with a high degree of disease activity.
Zentiva's Docetaxel Zentiva, previously known as Docetaxel Winthrop, in combination with androgen-deprivation therapy, with or without prednisone or prednisolone, for the treatment of patients with metastatic hormone-sensitive prostate cancer.
Sanofi(Euronext: SAN) and Regeneron Pharmaceuticals' (NYSE: REGN) Dupixent (dupilumab) for the treatment of certain adults with severe chronic rhinosinusitis with nasal polyposis.
Novartis' (NOVN: VX) anti-VEGF therapy Lucentis (ranibizumab)to include the treatment of proliferative diabetic retinopathy.
Celltrion's biosimilar Remisima (infliximab)in a new subcutaneous formulation, delivered via prefilled pens or syringes, in combination with methotrexate, for use in adults with rheumatoid arthritis.
Sanofi's Taxotere (docetaxel) to include use in combination with androgen-deprivation therapy, with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer.
Eli Lilly's (NYSE: KKY) GLP-1 receptor agonist Trulicity (dulaglutide)to include results from the REWIND cardiovascular outcomes trial, which achieved a significant 12% risk reduction in major adverse cardiovascular events, on the label.

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