Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2015

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.

Agenda and minutes

The agenda of the March 2015 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the April CHMP meeting.

CHMP statistics

Key figures from the March 2015 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP March 2015 meeting, is available in the grid below.

Positive recommendations on new medicines

Name of medicine	Akynzeo
International non-proprietary name (INN)	netupitant / palonosetron
Marketing-authorisation applicant	Helsinn Birex Pharmaceuticals Ltd
Therapeutic indication	Prevention of chemotherapy-induced nausea and vomiting
More information	CHMP summary of positive opinion for Akynzeo

Name of medicine	Gardasil 9
Common name	human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed)
Marketing-authorisation applicant	Sanofi Pasteur MSD SNC
Therapeutic indication	Treatment of HPV diseases
More information	CHMP summary of positive opinion for Gardasil 9 Press release: Gardasil 9 offers wider protection against cancers caused by human papillomavirus (HPV)

Name of medicine	Lenvima
INN	lenvatinib
Marketing-authorisation applicant	Eisai Europe Ltd
Therapeutic indication	Treatment of progressive, locally advanced or metastatic, differentiated thyroid cancer
More information	CHMP summary of positive opinion for Lenvima Press release: Accelerated assessment fast-tracks Lenvima to benefit patients with thyroid cancer

Name of medicine	Synjardy
INN	empagliflozin / metformin
Marketing-authorisation applicant	Boehringer Ingelheim GmbH
Therapeutic indication	Treatment of type 2 diabetes
More information	CHMP summary of positive opinion for Synjardy

Positive recommendation on new generic medicine

Name of medicine	Voriconazole Hospira
INN	voriconazole
Marketing-authorisation applicant	Hospira UK Limited
Therapeutic indication	Treatment of fungal infections
More information	CHMP summary of positive opinion for Voriconazole Hospira

Positive recommendation on new therapeutic indication

Name of medicine	Tamiflu
INN	oseltamivir
Marketing-authorisation holder	Roche Registration Ltd
More information	CHMP post-authorisation summary of positive opinion for Tamiflu

Public-health recommendation

Name of medicine	Aclasta
INN	zoledronic acid
Marketing-authorisation holder	Novartis Europharm Limited
More information	Further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine

Outcome of harmonisation procedure

Name of medicine	Ikorel and Dancor
INN	nicorandil
Marketing-authorisation holder	Sanofi-Aventis group of companies and associated companies / Merck group of companies and associated companies
More information	Ikorel and Dancor

Withdrawal of application

Name of medicine	Ketoconazole AID-SCFM
INN	ketoconazole
More information	Questions and answers on the withdrawal of the marketing authorisation application for Ketoconazole AID-SCFM (ketoconazole)