Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013

This page provides an overview of the opinions adopted at the September 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes. This month, the Committee recommended 11 new medicines for approval – the most medicines recommended for approval at a CHMP meeting so far in 2013.

Eleven new medicines recommended for approval

The CHMP recommended the approval of two medicines for cancer: Kadcyla for the treatment of metastatic breast cancer and Xofigo for the treatment of castration-resistant prostate cancer.

The Committee also gave positive recommendations for three medicines intended to treat neurological disorders: Abilify Maintena for the treatment of schizophrenia, Memantine Accord, a generic medicine, for the treatment of Alzheimer's disease and Levodopa/Carbidopa/Entacapone Sandoz, which was submitted as a so-called informed consent application, for the treatment of adult patients with Parkinson's disease.

The CHMP also recommended that Vitekta should be granted marketing authorisation for the treatment of human-immunodeficiency-virus‑1 (HIV‑1) infection in adults who are infected with HIV‑1 without known mutations associated with resistance to elvitegravir.

Invokana received a positive opinion for marketing authorisation for the treatment of type-2 diabetes mellitus.

NovoEight was recommended for marketing authorisation for the treatment of haemophilia A and Relvar Ellipta received a positive opinion from the Committee for the treatment of asthma and chronic obstructive pulmonary disorder (COPD).

The vaccine Fluenz Tetra was recommended for a marketing authorisation for the prevention of influenza in children and adolescents 24 months to less than 18 years of age.

The Committee recommended that Lidocaine/Prilocaine Plethora should be granted marketing authorisation for the treatment of primary premature ejaculation in adult men.

Four recommendations on extensions of therapeutic indications

The CHMP recommended an extension to the existing indications for Cimzia, Kineret, Votubia and Yervoy.

Two re-examination procedures for referral opinions started

The CHMP started a re-examination procedure for dihydroergotoxine, one of the medicines included in the Article-31 referral procedure on ergot derivatives. The other ergot derivatives in this referral are not included in this re-examination.

The Committee also started a re-examination procedure for metoclopramide-containing medicines.

More information on these, and all other outcomes of this month's meeting, are available in the table below.

CHMP welcomes new members

At the September CHMP, Daniel Brasseur, former Chair of the Paediatric Committee (PDCO), replaced Pieter Neels as the Belgian CHMP member. Before joining the PDCO, Dr Brasseur was chair of the CHMP. Pieter de Graeff replaced Barbara van Zwieten-Boot as the new CHMP member from the Netherlands, and Greg Markey became the new CHMP member from the United Kingdom, replacing Ian Hudson, who was recently appointed Chief Executive of the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA).

Positive recommendations on new medicines

Name of medicine	Abilify Maintena
International non-proprietary name (INN)	aripiprazole
Marketing-authorisation applicant	Otsuka Pharmaceutical Europe Ltd
Therapeutic indication	Treatment of schizophrenia
More information	Summary of opinion for Abilify Maintena

Name of medicine	Fluenz Tetra
Common name	influenza vaccine (live attenuated, nasal)
Marketing-authorisation applicant	MedImmune LLC
Therapeutic indication	Prophylaxis of influenza in children and adolescents 24 months to less than 18 years of age
More information	Summary of opinion for Fluenz Tetra

Name of medicine	Invokana
INN	canagliflozin
Marketing-authorisation applicant	Janssen-Cilag International N.V.
Therapeutic indication	Treatment of type-2 diabetes mellitus
More information	Summary of opinion for Invokana

Name of medicine	Kadcyla
INN	trastuzumab emtansine
Marketing-authorisation applicant	Roche Registration Ltd
Therapeutic indication	Treatment of metastatic breast cancer
More information	Summary of opinion for Kadcyla

Name of medicine	Lidocaine/Prilocaine Plethora
INN	lidocaine / prilocaine
Marketing-authorisation applicant	Plethora Solutions Ltd
Therapeutic indication	Treatment of primary premature ejaculation in adult men
More information	Summary of opinion for Lidocaine/Prilocaine Plethora

Name of medicine	NovoEight
INN	turoctocog alfa
Marketing-authorisation applicant	Novo Nordisk A/S
Therapeutic indication	Treatment of haemophilia A (congenital factor-VIII deficiency)
More information	Summary of opinion for NovoEight

Name of medicine	Relvar Ellipta
INN	fluticasone furoate / vilanterol
Marketing-authorisation applicant	Glaxo Group Ltd
Therapeutic indication	Treatment of asthma and chronic obstructive pulmonary disorder (COPD)
More information	Summary of opinion for Relvar Ellipta

Name of medicine	Vitekta
INN	elvitegravir
Marketing-authorisation applicant	Gilead Sciences International Ltd
Therapeutic indication	Treatment of human-immunodeficiency-virus‑1 (HIV‑1) infection in adults who are infected with HIV‑1 without known mutations associated with resistance to elvitegravir
More information	Summary of opinion for Vitekta

Name of medicine	Xofigo
INN	radium-223
Marketing-authorisation applicant	Bayer Pharma AG
Therapeutic indication	Treatment of castration-resistant prostate cancer
More information	Summary of opinion for Xofigo

Positive recommendation on new informed-consent application

Name of medicine	Levodopa/Carbidopa/Entacapone Sandoz
INN	levodopa / carbidopa / entacapone
Marketing-authorisation applicant	Orion Corporation
Therapeutic indication	Treatment of adult patients with Parkinson's disease
More information	Summary of opinion for Levodopa/Carbidopa/Entacapone Sandoz

Positive recommendation on new generic medicine

Name of medicine	Memantine Accord
INN	memantine
Marketing-authorisation applicant	Accord Healthcare Limited
Therapeutic indication	Treatment of Alzheimer's disease
More information	Summary of opinion for Memantine Accord

Positive recommendations on extensions of therapeutic indications

Name of medicine	Cimzia
INN	certolizumab pegol
Marketing-authorisation holder	UCB Pharma SA
More information	Summary of opinion for Cimzia

Name of medicine	Kineret
INN	anakinra
Marketing-authorisation holder	Biovitrum AB (publ)
More information	Summary of opinion for Kineret

Name of medicine	Votubia
INN	everolimus
Marketing-authorisation holder	Novartis Europharm Ltd
More information	Summary of opinion for Votubia

Name of medicine	Yervoy
INN	ipilimumab
Marketing-authorisation holder	Bristol-Myers Squibb Pharma EEIG
More information	Summary of opinion for Yervoy

Recommendations for new contraindications

Name of medicine	Ipreziv
INN	azilsartan medoxomil
Marketing-authorisation holder	Takeda Global Research and Development Centre (Europe) Ltd
More information	Summary of opinion for Ipreziv

Name of medicine	Thymanax
INN	agomelatine
Marketing-authorisation holder	Servier (Ireland) Industries Ltd
More information	Summary of opinion for Thymanax

Name of medicine	Valdoxan
INN	agomelatine
Marketing-authorisation holder	Les Laboratoires Servier
More information	Summary of opinion for Valdoxan

Outcome of arbitration procedure

Re-examinations started

Other updates

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

Opinions on safety variations / periodic safety update reports

Start of Community reviews

Scientific advice and protocol assistance

Guidelines and concept papers adopted

Overview of invented names reviewed in September 2013 by the Name Review Group (NRG)

Organisational matters

Opinions on consultation procedures on ancillary medicinal substances in medical devices