Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 June 2014

News 27/06/2014

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

Six new medicines recommended for approval

The CHMP has recommended granting a marketing authorisation for Daklinza (daclatasvir) in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults. Please see the press release in the grid below for more information.

Abasria (insulin glargine) received a positive opinion for a marketing authorisation for the treatment of diabetes mellitus. Abasria is the first biosimilar insulin to be recommended for marketing authorisation in the European Union.

Vizamyl (flutemetamol (18F)) was recommended for the visual detection of amyloid-beta neuritic plaques in the brain.

Triumeq (abacavir sulfate / dolutegravir sodium / lamivudine) received a positive opinion for a marketing authorisation for the treatment of human immunodeficiency virus (HIV) infection in adults and adolescents from 12 years of age weighing at least 40 kg.

The CHMP gave a positive recommendation for Velphoro (mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) for the control of serum phosphorus levels in patients with end-stage renal disease.

The Committee also recommended granting a marketing authorisation for Clopidogrel / Acetylsalicylic acid Teva (clopidogrel / acetylsalicylic acid) for the prevention of atherothrombotic events.

Positive opinion on Vantobra adopted by written procedure

In addition to the positive opinions for the six new medicines adopted at the June 2014 meeting, the EMA would also like to highlight the CHMP's recommendation to grant a marketing authorisation for the hybrid medicine Vantobra (tobramycin), adopted via written procedure on 2 June 2014.

Seven recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Avastin, Eliquis, Enbrel, Eylea, Isentress, Kalydeco and Stivarga.

Re-examination of negative opinion on extension of indication for Avastin requested

The marketing-authorisation holder for Avastin has requested a re-examination of the CHMP's negative opinion recommending the refusal of a change to the marketing authorisation for this medicine, adopted at its May 2014 meeting. The change concerned an extension of indication to add treatment of glioblastoma (an aggressive type of brain cancer). Upon receipt of the grounds of the request for re-examination, the CHMP will re-examine this opinion and issue a final opinion.

Withdrawals of applications

The applications for marketing authorisation for Faldaprevir Boehringer Ingelheim (faldaprevir), and for an extension of indication for Tasigna (nilotinib) have been withdrawn. For more information, please see question-and-answer documents in the grid below.

Agenda and minutes

The agenda of the June 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the July CHMP meeting. Minutes of the May 2014 CHMP meeting will be published next week.

CHMP statistics

Key figures from the June 2014 CHMP meeting are represented in the graphic below. The total number of positive new opinions includes the hybrid medicine Vantobra, which was adopted by the Committee by written procedure in June 2014.

Positive recommendations on new medicines

Name of medicineDaklinza
International non-proprietary name (INN)daclatasvir
Marketing-authorisation applicantBristol-Myers Squibb Pharma EEIG
Therapeutic indicationTreatment of chronic hepatitis C virus (HCV)
More information PDF iconSummary of opinion for Daklinza
Press release: European Medicines Agency recommends approval of Daklinza in chronic hepatitis C

Name of medicineTriumeq
INNabacavir sulfate / dolutegravir sodium / lamivudine
Marketing-authorisation applicantViiV Healthcare Uk Limited
Therapeutic indicationTreatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age weighing at least 40 kg
More information PDF iconSummary of opinion for Triumeq

Name of medicineVelphoro
INNmixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches
Marketing-authorisation applicantVifor Fresenius Medical Care Renal Pharma France
Therapeutic indicationIndicated for the control of serum phosphorus levels in patients with end-stage renal disease
More information PDF iconSummary of opinion for Velphoro

Name of medicineVizamyl
INNflutemetamol (18F)
Marketing-authorisation applicantGE Healthcare Ltd
Therapeutic indicationIndicated for the visual detection of amyloid-beta neuritic plaques in the brain
More information PDF iconSummary of opinion for Vizamyl

Name of medicineClopidogrel / Acetylsalicylic acid Teva
INNclopidogrel / acetylsalicylic acid
Marketing-authorisation applicantTeva Pharma B.V.
Therapeutic indicationPrevention of atherothrombotic events
More information PDF iconSummary of opinion for Clopidogrel / Acetylsalicylic acid Teva

Recommendation for new biosimilar medicine

Name of medicineAbasria
INNinsulin glargine
Marketing-authorisation applicantEli Lilly Regional Operations GmbH
Therapeutic indicationTreatment of diabetes mellitus
More information PDF iconSummary of opinion for Abasria

Positive recommendations on new therapeutic indications

Name of medicineAvastin
INNbevacizumab
Marketing-authorisation applicantRoche Registration Ltd
More information PDF iconSummary of opinion for Avastin

Name of medicineEliquis
INNapixaban
Marketing-authorisation applicantBristol-Myers Squibb / Pfizer EEIG
More information PDF iconSummary of opinion for Eliquis

Name of medicineEnbrel
INNetanercept
Marketing-authorisation applicantPfizer Ltd
More information PDF iconSummary of opinion for Enbrel

Name of medicineEylea
INNaflibercept
Marketing-authorisation applicantBayer Pharma AG
More informationSummary of opinion for Eylea

Name of medicineIsentress
INNraltegravir
Marketing-authorisation applicantMerck Sharp & Dohme Ltd
More information PDF iconSummary of opinion for Isentress

Name of medicineKalydeco
INNivacaftor
Marketing-authorisation applicantVertex Pharmaceuticals (UK) Ltd
More information PDF iconSummary of opinion for Kalydeco

Name of medicineStivarga
INNregorafenib
Marketing-authorisation applicantBayer Pharma AG
More information PDF iconSummary of opinion for Stivarga

Outcome of arbitration procedure

Name of medicine Seasonique and associated names
INNlevonogestrel 150 μg and ethinylestradiol 30 μg / 10 μg
More informationQuestions and answers on Seasonique and associated names

Outcomes of harmonisation procedures

Name of medicine Sandostatin and associated names
INNoctreotide acetate
More informationQuestions and answers on Sandostatin and associated names

Name of medicine Sandostatin LAR and associated names
INNoctreotide acetate
More informationQuestions and answers on Sandostatin LAR and associated names

Withdrawal of application

Name of medicineFaldaprevir Boehringer Ingelheim
INNfaldaprevir
More information PDF iconQuestions and answers on Faldaprevir Boehringer Ingelheim

Withdrawal of application for extension of therapeutic indication

Name of medicineTasigna
INNnilotinib
Marketing-authorisation applicantNovartis Europharm Ltd
More information PDF iconQuestions and answers on Tasigna

Other updates

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

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