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

News 27/03/2015

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 medicineAkynzeo
International non-proprietary name (INN)netupitant / palonosetron
Marketing-authorisation applicantHelsinn Birex Pharmaceuticals Ltd
Therapeutic indicationPrevention of chemotherapy-induced nausea and vomiting
More information PDF iconSummary of opinion for Akynzeo

Name of medicineGardasil 9
Common namehuman papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed)
Marketing-authorisation applicantSanofi Pasteur MSD SNC
Therapeutic indicationTreatment of HPV diseases
More information

PDF iconSummary of opinion for Gardasil 9

Press release: Gardasil 9 offers wider protection against cancers caused by human papillomavirus (HPV)

Name of medicineLenvima
INNlenvatinib
Marketing-authorisation applicantEisai Europe Ltd
Therapeutic indicationTreatment of progressive, locally advanced or metastatic, differentiated thyroid cancer
More information

PDF iconSummary of opinion for Lenvima

Press release: Accelerated assessment fast-tracks Lenvima to benefit patients with thyroid cancer

Name of medicineSynjardy
INNempagliflozin / metformin
Marketing-authorisation applicantBoehringer Ingelheim GmbH
Therapeutic indicationTreatment of type 2 diabetes
More information PDF iconSummary of opinion for Synjardy

Positive recommendation on new generic medicine

Name of medicineVoriconazole Hospira
INNvoriconazole
Marketing-authorisation applicantHospira UK Limited
Therapeutic indicationTreatment of fungal infections
More information PDF iconSummary of opinion for Voriconazole Hospira

Positive recommendation on new therapeutic indication

Name of medicineTamiflu
INNoseltamivir
Marketing-authorisation holderRoche Registration Ltd
More information

PDF iconSummary of opinion for Tamiflu

Public-health recommendation

Name of medicineAclasta
INNzoledronic acid
Marketing-authorisation holderNovartis Europharm Limited
More informationFurther measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine

Outcome of harmonisation procedure

Name of medicineIkorel and Dancor
INNnicorandil
Marketing-authorisation holderSanofi-Aventis group of companies and associated companies / Merck group of companies and associated companies
More informationIkorel and Dancor

Withdrawal of application

Name of medicineKetoconazole AID-SCFM
INNketoconazole
More information PDF iconQuestions and answers on Ketoconazole AID-SCFM

Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
PDF iconStart of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
Overview of invented names reviewed in March 2015 by the Name Review Group (NRG)
PDF iconOrganisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

How useful was this page?

Add your rating