EMA Highlights: Green light for new medicines

by Gary Finnegan: Eight new medicines have been approved by the European Medicines Agency at its summer meeting. The influential Committee for Medicinal Products for Human use (CHMP) has now approved a total of 45 medicines in 2016.

Marketing authorisations were recommended for the following products:

  • Cabometyx(cabozantinib) and Kisplyx (lenvatinib) for the treatment of adult patients with advanced renal cell carcinoma who have been previously treated with a vascular endothelial growth factor (VEGF) inhibitor. Cabometyx is to be used as monotherapy while Kisplyx is for use in combination with everolimus.
  • Sialanar(glycopyrronium bromide) for severe drooling in children and adolescents with neurological disorders. This followed a re-examination of the Committee’s earlier negative opinion.
  • Onivyde(irinotecan) for the treatment of metastatic adenocarcinoma of the pancreas.
  • Truberzi(eluxadoline) for the treatment of irritable bowel syndrome with diarrhoea.
  • Tenofovir disoproxil Zentiva(tenofovir disoproxil) for the treatment of HIV-1 infection and chronic hepatitis B.
  • Twobiosimilar medicines, Inhixa and Thorinane (both containing enoxaparin sodium), for the prevention and treatment of various disorders related to blood clots in adults.