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

News 25/07/2014

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The application for a marketing authorisation for Neofordex has been withdrawn.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 medicineImbruvica
International non-proprietary name (INN)ibrutinib
Marketing-authorisation applicantJanssen-Cilag International NV
Therapeutic indicationTreatment of relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukaemia
More information PDF iconSummary of opinion for Imbruvica
Press release: European Medicines Agency recommends approval of two new treatment options for rare cancers

Name of medicineXultophy
INNinsulin degludec / liraglutide
Marketing-authorisation applicantNovo Nordisk A/S
Therapeutic indicationTreatment of type 2 diabetes mellitus
More information PDF iconSummary of opinion for Xultophy

Name of medicineZydelig
INNidelalisib
Marketing-authorisation applicantGilead Sciences International Ltd
Therapeutic indicationTreatment of patients with chronic lymphocytic leukaemia and patients with refractory follicular lymphoma
More information PDF iconSummary of 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 medicineBusulfan Fresenius Kabi
INNbusulfan
Marketing-authorisation applicantFresenius Kabi Oncology Plc
Therapeutic indicationConditioning treatment prior to conventional haematopoietic progenitor cell transplantation
More information PDF iconSummary of opinion for Busulfan Fresenius Kabi

Positive recommendation on new biosimilar medicine

Name of medicineAccofil
INNfilgrastim
Marketing-authorisation applicantAccord Healthcare Ltd
Therapeutic indicationTreatment of neutropenia
More information PDF iconSummary of opinion for Accofil

Positive recommendations on extensions of therapeutic indications

Name of medicineBaraclude
INNentecavir
Marketing-authorisation applicantBristol-Myers Squibb Pharma EEIG
More information PDF iconSummary of opinion for Baraclude

Name of medicineBusilvex
INNbusulfan
Marketing-authorisation applicantPierre Fabre Médicament
More information PDF iconSummary of opinion for Busilvex

Name of medicineEcalta
INNanidulafungin
Marketing-authorisation applicantPfizer Limited
More information PDF iconSummary of opinion for Ecalta

Name of medicineHumira
INNadalimumab
Marketing-authorisation applicantAbbVie Ltd
More information PDF iconSummary of opinion for Humira

Name of medicineOzurdex
INNdexamethasone
Marketing-authorisation applicantAllergan Pharmaceuticals Ireland
More information PDF iconSummary of opinion for Ozurdex

Name of medicineRoActemra
INNtocilizumabum
Marketing-authorisation applicantRoche Registration Ltd
More information PDF iconSummary of opinion for RoActemra

Name of medicineXgeva
INNdenosumab
Marketing-authorisation applicantAmgen Europe B.V.
More information PDF iconSummary of opinion for Xgeva

Public-health recommendation

Name of medicineEmergency contraceptives
INNlevonorgestrel / ulipristal acetate
More informationEmergency contraceptives

Withdrawal of application

Name of medicineNeofordex
INN dexamethasone acetate
Marketing-authorisation applicant Laboratoires Ctrs - Boulogne Billancourt
More information PDF iconQuestions and answers on Neofordex

Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
Start of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
PDF iconOverview of invented names reviewed in July 2014 by the Name Review Group (NRG)
PDF iconOrganisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

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