EMA Recommends Seven Medicines for Authorization

December 16, 2016

The agency announces that 81 medicines overall were recommended in 2016.

The European Medicines Agency (EMA) recommended seven new medicines for marketing authorization at its December 2016 meeting, bringing the total on recommendations to 81 for 2016. The new drugs target forms of arthritis, lung cancer, non-Hodgkin’s lymphoma, hemophilia, and epilepsy, among other conditions.

EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended granting market authorization for the following:

  • Olumiant (baricitinib) for the treatment of moderate to severe active rheumatoid arthritis.

  • Alecensa (alectinib) for the treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

  • Lifmior (etanercept) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and pediatric plaque psoriasis.

  • Truxima (rituximab), a biosimilar, for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

  • Ledaga (chormethine), a hybrid medicine, for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma..

  • Pregabalin Zentiva k.s (pregabalin), a generic, for the treatment of epilepsy, neuropathic pain, and generalized anxiety disorder.

  • Vihuma (simoctocog alfa) for the prevention and treatment of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

CHMP also recommended extending indications for Ameluz, Cinryze, Ilaris, Jardiance, Jentadueto, Keytruda, Tivacy, Trajenta and Votubia.

Source: EMA