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

News 20/09/2013

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 medicineAbilify Maintena
International non-proprietary name (INN)aripiprazole
Marketing-authorisation applicantOtsuka Pharmaceutical Europe Ltd
Therapeutic indicationTreatment of schizophrenia
More information PDF iconSummary of opinion for Abilify Maintena

Name of medicineFluenz Tetra
Common nameinfluenza vaccine (live attenuated, nasal)
Marketing-authorisation applicantMedImmune LLC
Therapeutic indicationProphylaxis of influenza in children and adolescents 24 months to less than 18 years of age
More information PDF iconSummary of opinion for Fluenz Tetra

Name of medicineInvokana
INNcanagliflozin
Marketing-authorisation applicantJanssen-Cilag International N.V.
Therapeutic indicationTreatment of type-2 diabetes mellitus
More information PDF iconSummary of opinion for Invokana

Name of medicineKadcyla
INNtrastuzumab emtansine
Marketing-authorisation applicantRoche Registration Ltd
Therapeutic indicationTreatment of metastatic breast cancer
More information PDF iconSummary of opinion for Kadcyla

Name of medicineLidocaine/Prilocaine Plethora
INNlidocaine / prilocaine
Marketing-authorisation applicantPlethora Solutions Ltd
Therapeutic indicationTreatment of primary premature ejaculation in adult men
More information PDF iconSummary of opinion for Lidocaine/Prilocaine Plethora

Name of medicineNovoEight
INNturoctocog alfa
Marketing-authorisation applicantNovo Nordisk A/S
Therapeutic indicationTreatment of haemophilia A (congenital factor-VIII deficiency)
More information PDF iconSummary of opinion for NovoEight

Name of medicineRelvar Ellipta
INNfluticasone furoate / vilanterol
Marketing-authorisation applicantGlaxo Group Ltd
Therapeutic indicationTreatment of asthma and chronic obstructive pulmonary disorder (COPD)
More information PDF iconSummary of opinion for Relvar Ellipta

Name of medicineVitekta
INNelvitegravir
Marketing-authorisation applicantGilead Sciences International Ltd
Therapeutic indicationTreatment 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 PDF iconSummary of opinion for Vitekta

Name of medicineXofigo
INNradium-223
Marketing-authorisation applicantBayer Pharma AG
Therapeutic indicationTreatment of castration-resistant prostate cancer
More information PDF iconSummary of opinion for Xofigo

Positive recommendation on new informed-consent application

Name of medicineLevodopa/Carbidopa/Entacapone Sandoz
INNlevodopa / carbidopa / entacapone
Marketing-authorisation applicantOrion Corporation
Therapeutic indicationTreatment of adult patients with Parkinson's disease
More information PDF iconSummary of opinion for Levodopa/Carbidopa/Entacapone Sandoz

Positive recommendation on new generic medicine

Name of medicineMemantine Accord
INNmemantine
Marketing-authorisation applicantAccord Healthcare Limited
Therapeutic indicationTreatment of Alzheimer's disease
More information PDF iconSummary of opinion for Memantine Accord

Positive recommendations on extensions of therapeutic indications

Name of medicineCimzia
INNcertolizumab pegol
Marketing-authorisation holderUCB Pharma SA
More information PDF iconSummary of opinion for Cimzia

Name of medicineKineret
INNanakinra
Marketing-authorisation holderBiovitrum AB (publ)
More information PDF iconSummary of opinion for Kineret

Name of medicineVotubia
INNeverolimus
Marketing-authorisation holderNovartis Europharm Ltd
More information PDF iconSummary of opinion for Votubia

Name of medicineYervoy
INNipilimumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More information PDF iconSummary of opinion for Yervoy

Recommendations for new contraindications

Name of medicineEdarbi
INNazilsartan medoxomil
Marketing-authorisation holderTakeda Global Research and Development Centre (Europe) Ltd
More informationSummary of opinion for Edarbi

Name of medicineIpreziv
INNazilsartan medoxomil
Marketing-authorisation holderTakeda Global Research and Development Centre (Europe) Ltd
More information PDF iconSummary of opinion for Ipreziv

Name of medicineThymanax
INNagomelatine
Marketing-authorisation holderServier (Ireland) Industries Ltd
More information PDF iconSummary of opinion for Thymanax

Name of medicineValdoxan
INNagomelatine
Marketing-authorisation holderLes Laboratoires Servier
More information PDF iconSummary of opinion for Valdoxan

Outcome of arbitration procedure

Name of medicineDidanosine
INNdidanosine
Marketing-authorisation holderAurobindo Pharma (Malta) Limited
More informationDidanosine

Re-examinations started

Name of medicineErgot derivatives
INNdihydroergotoxine
More informationErgot derivatives

Name of medicineMetoclopramide-containing medicines
INNmetoclopramide
More informationMetoclopramide-containing medicines

Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations / periodic safety update reports
PDF iconStart of Community reviews
Scientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
Overview of invented names reviewed in September 2013 by the Name Review Group (NRG)
PDF iconOrganisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

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