EMA green light for new medicines

by Gary Finnegan: Five new medicines have been recommended for approval at the latest meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use

  • Lenvima (lenvatinib), for the treatment of adults with progressive, locally advanced or metastatic differentiated thyroid carcinoma, whose disease has progressed despite receiving radioactive iodine.
    Lenvima was reviewed under EMA’s accelerated assessment programme which provides for an expedited review of medicines that, if approved, would significantly improve the treatment of this serious condition. The medicine also received an orphan designation in 2013 because the condition it is intended to treat was considered a rare disease.
  • Gardasil 9, a human papillomavirus (HPV) vaccine, for the prevention of certain diseases caused by nine types of HPV (types 6, 11, 16, 18, 31, 33, 45, 52, 58). Gardasil 9 covers five more HPV types than Gardasil.
  • Akynzeo (netupitant / palonosetron), for the prevention of chemotherapy-induced nausea and vomiting.
  • Synjardy (empagliflozin / metformin) for the treatment of type 2 diabetes.
  • The generic medicine Voriconazole Hospira (voriconazole) for the treatment of fungal infections.

The Committee also recommended an extension of indication for Tamiflu to include the treatment of influenza in infants below one year of age.

In addition, the CHMP has adopted recommendations for Aclasta (zoledronic acid), following a periodic review of the medicine by the PRAC. Aclasta is one of several bisphosphonate medicines with a known risk of osteonecrosis of the jaw.

The review concluded that the risk with this medicine remains very low, but has recommended a number of measures to minimise the risk, including an update to the product information and the introduction of a patient reminder card.

Similar measures are planned over the course of 2015/2016 for other intravenous bisphosphonates and another medicine, denosumab, which also has an osteonecrosis risk.