Five new medicines, including one orphan, recommended for approval

Five new medicines have been recommended for approval at the March 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP).

The CHMP has recommended granting a marketing authorisation for 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 program. This program 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. For more information on Lenvima, please see the press release in the grid below.

The Committee has recommended granting a marketing authorisation for 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. For more information on Gardasil 9, please see the press release in the grid below.

Akynzeo (netupitant / palonosetron) has been recommended for marketing authorisation for the prevention of chemotherapy-induced nausea and vomiting.

Synjardy (empagliflozin / metformin) received a positive opinion from the Committee for the treatment of type 2 diabetes.

The generic medicine Voriconazole Hospira (voriconazole) also received a positive opinion from the CHMP for the treatment of fungal infections.

One recommendation on extension of therapeutic indication

The Committee 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 (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.

More information is available in the public health communication in the grid below.

Withdrawal of application

The application for a marketing authorisation for Ketoconazole AID-SCFM (ketoconazole) has been withdrawn. A question-and-answer document on this withdrawal is available in the grid below.


Posted on the EMA website on 27 March 2015