Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2014

This page provides an overview of the opinions adopted at the July 2014 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

Five new medicines recommended for approval

The CHMP has recommended granting marketing authorisations for two new medicines for the treatment of various rare cancers of the blood, Imbruvica (ibrutinib) and Zydelig (idelalisib). Please see the press release in the grid below for more information.

Granting a marketing authorisation to Xultophy (insulin degludec/liraglutide) for the treatment of diabetes mellitus has also been recommended.

The CHMP recommended granting a marketing authorisation for Accofil (filgrastim), a biosimilar medicine intended for the treatment of neutropenia.

The generic medicine Busulfan Fresenius Kabi (busulfan) was also recommended for authorisation for conditioning treatment prior to conventional haematopoietic progenitor cell transplantation.

Seven recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Baraclude, Busilvex, Ecalta, Humira, Ozurdex, RoActemra and Xgeva.

Outcome of review on emergency contraceptives

The CHMP has concluded its review of emergency contraceptives containing levonorgestrel and ulipristal acetate.

Withdrawal of application

The application for a marketing authorisation for Neofordex has been withdrawn. For more information, please see question-and-answer document in the grid below.

Agenda and minutes

The agenda of the July 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the next meeting of the CHMP which will take place from 22-25 September 2014. Minutes of the June 2014 CHMP meeting will be published next week.

CHMP statistics

Key figures from the July 2014 CHMP meeting are represented in the graphic below.

Positive recommendations on new medicines

Name of medicine	Imbruvica
International non-proprietary name (INN)	ibrutinib
Marketing-authorisation applicant	Janssen-Cilag International NV
Therapeutic indication	Treatment of relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukaemia
More information	CHMP summary of positive opinion for Imbruvica
	Press release: European Medicines Agency recommends approval of two new treatment options for rare cancers

Name of medicine	Xultophy
INN	insulin degludec / liraglutide
Marketing-authorisation applicant	Novo Nordisk A/S
Therapeutic indication	Treatment of type 2 diabetes mellitus
More information	CHMP summary of positive opinion for Xultophy

Name of medicine	Zydelig
INN	idelalisib
Marketing-authorisation applicant	Gilead Sciences International Ltd
Therapeutic indication	Treatment of patients with chronic lymphocytic leukaemia and patients with refractory follicular lymphoma
More information	CHMP summary of positive opinion for Zydelig
	Press release: European Medicines Agency recommends approval of two new treatment options for rare cancers

Positive recommendation on new generic medicine

Name of medicine	Busulfan Fresenius Kabi
INN	busulfan
Marketing-authorisation applicant	Fresenius Kabi Oncology Plc
Therapeutic indication	Conditioning treatment prior to conventional haematopoietic progenitor cell transplantation
More information	CHMP summary of positive opinion for Busulfan Fresenius Kabi

Positive recommendation on new biosimilar medicine

Name of medicine	Accofil
INN	filgrastim
Marketing-authorisation applicant	Accord Healthcare Ltd
Therapeutic indication	Treatment of neutropenia
More information	CHMP summary of positive opinion for Accofil

Positive recommendations on extensions of therapeutic indications

Name of medicine	Baraclude
INN	entecavir
Marketing-authorisation applicant	Bristol-Myers Squibb Pharma EEIG
More information	CHMP post-authorisation summary of positive opinion for Baraclude

Name of medicine	Busilvex
INN	busulfan
Marketing-authorisation applicant	Pierre Fabre Médicament
More information	CHMP post-authorisation summary of positive opinion for Busilvex

Name of medicine	Ecalta
INN	anidulafungin
Marketing-authorisation applicant	Pfizer Limited
More information	CHMP post-authorisation summary of positive opinion for Ecalta

Name of medicine	Humira
INN	adalimumab
Marketing-authorisation applicant	AbbVie Ltd
More information	CHMP post-authorisation summary of positive opinion for Humira

Name of medicine	Ozurdex
INN	dexamethasone
Marketing-authorisation applicant	Allergan Pharmaceuticals Ireland
More information	CHMP post-authorisation summary of positive opinion for Ozurdex

Name of medicine	RoActemra
INN	tocilizumabum
Marketing-authorisation applicant	Roche Registration Ltd
More information	CHMP post-authorisation summary of positive opinion for RoActemra

Name of medicine	Xgeva
INN	denosumab
Marketing-authorisation applicant	Amgen Europe B.V.
More information	CHMP post-authorisation summary of positive opinion for Xgeva

Public-health recommendation

Name of medicine	Emergency contraceptives
INN	levonorgestrel / ulipristal acetate
More information	Emergency contraceptives

Withdrawal of application

Name of medicine	Neofordex
INN	dexamethasone acetate
Marketing-authorisation applicant	Laboratoires Ctrs - Boulogne Billancourt
More information	Questions and answers on the withdrawal of the marketing-authorisation application for Neofordex