Medicinal Products

CHMP News – March 2015


CHMP has recommended five new medicines for approval

At its march 2015 meeting the EMA’s Committee recommended five new medicines for approval..

CHMP has recommended the following:

  • Granting a marketing authorisation for an orphan medicine Lenvima (lenvatinib) for the treatment of adults with progressive, locally advanced or metastatic differentiated thyroid carcinoma, whose disease has progressed despite receiving radioactive iodine.
  • Granting a marketing authorisation for Gardasil 9, vaccine against human papillomavirus (HPV), for the prevention of certain diseases caused by nine types of HPV (types 6, 11, 16, 18, 31, 33, 45, 52 and 58).
  • Granting a marketing authorisation for Akynzeo (netupitant/palonosetron) for the prevention of chemotherapy-induced nausea and vomiting.
  • Granting a marketing authorisation for Synjardy (empagliflozin/metformin) for the treatment of type 2 diabetes.
  • Granting a marketing authorisation for the generic medicine Voriconazole Hospira (voriconazole) for the treatment of fungal infections.

Recommendation on extension of therapeutic indication

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

Outcome of periodic review

The CHMP has adopted recommendations for Aclasta (zolendronic acid), following a peridodic 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 has an osteonecrosis risk.

More on the CHMP March 2015 meeting is available on the EMA webpages, or here.