Five new medicines, including one orphan, recommended for approval

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

 

London (March 27, 2015) – 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.

 

 

CHMP_highlights_March_2015.png

 

 

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

Summary of 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

Summary of 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

Summary of 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

Summary of 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

Summary of opinion for Voriconazole Hospira

 

 

Positive recommendation on new therapeutic indication

 

Name of medicine

Tamiflu

INN

oseltamivir

Marketing-authorisation holder

Roche Registration Ltd

More information

Summary of 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 Ketoconazole AID-SCFM

 

 

Other updates

 

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures

Opinions on safety variations

Start of Community reviews

Scientific advice and protocol assistance

Guidelines and concept papers adopted

Overview of invented names reviewed in March 2015 by the Name Review Group (NRG)

Organisational matters

Opinions on consultation procedures on ancillary medicinal substances in medical devices

 


 

European Medicines Agency, 27.03.2015 (tB).

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