Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 2015

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25/09/2015

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 2015

19 new medicines, of which two have been fast-tracked, receive positive opinions from the Committee

At its busiest meeting of 2015 so far, the Committee for Medicinal Products for Human Use (CHMP) recommended 19 new medicines for marketing authorisation.

The Committee recommended granting a marketing authorisation, under accelerated assessment, for Praxbind (idarucizumab) as a specific antidote to the anticoagulant medicine Pradaxa (dabigatran etexilate), when rapid reversal of its effect is required. Praxbind is to be used when a patient taking Pradaxa needs to undergo an emergency surgery or when life-threatening or uncontrolled bleeding occurs. For more information on Praxbind, please see the press release in the grid below.

Entresto (sacubitril / valsartan) was recommended for the treatment of symptomatic chronic heart failure with reduced ejection fraction - a condition where the heart muscle does not contract effectively and less oxygen-rich blood is pumped out to the body. For more information on Entresto, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Kyprolis (carfilzomib) to treat patients with multiple myeloma whose disease has relapsed after receiving at least one prior course of therapy. Kyprolis is for use in combination with the medicines lenalidomide and dexamethasone. Kyprolis has an orphan designation and was reviewed under accelerated assessment. For more information on Kyprolis, please see the press release in the grid below.

The CHMP recommended granting a conditional marketing authorisation for Blincyto (blinatumomab) for the treatment of Philadelphia chromosome-negative acute lymphoblastic leukaemia. Conditional marketing authorisations are one of the mechanisms put in place by the Agency to facilitate market access for medicines that fulfill unmet medical needs. Blincyto has an orphan designation.

Cotellic (cobimetinib) was recommended by the Committee for the treatment of metastatic melanoma.

Genvoya (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide) received a positive opinion from the Committee for the treatment of Human Immunodeficiency Virus (HIV) infection.

The CHMP recommended Nucala (mepolizumab) for the treatment of asthma and Orkambi (lumacaftor / ivacaftor) for the treatment of cystic fibrosis. Orkambi has an orphan designation.

Numient (levodopa / carbidopa) received a positive opinion from the Committee for the treatment of Parkinson’s disease.

The Committee also granted positive opinions for Ionsys (fentanyl) for the treatment of post-operative pain, as well as Elocta (efmoroctocog alfa) for the treatment of haemophilia A. Elocta has an orphan designation.

Ravicti (glycerol phenylbutyrate), which also has an orphan designation, received a positive opinion from the Committee for the treatment of urea cycle disorders.

Ebymect (dapagliflozin / metformin) and Edistride (dapagliflozin) received positive opinions for the treatment of type 2 diabetes mellitus. These medicines were submitted as informed consent applications. This means that the applications make use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

Five generic medicines received positive opinions from the CHMP: Aripiprazole Accord (aripiprazole) for the treatment of schizophrenia and the prevention and treatment of manic episodes of bipolar 1 disorder, Ciambra (pemetrexed), Pemetrexed Hospira (pemetrexed) and Pemetrexed Medac (pemetrexed) all to be used for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer, and Cinacalcet Mylan (cinacalcet) for the treatment of hyperparathyroidism and parathyroid carcinoma.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Eylea, Gilenya, Kalydeco, Opdivo, Rebetol and Vidaza.

Agenda and minutes

The agenda of the September 2015 meeting is published on EMA’s website. Minutes of the July 2015 CHMP meeting will be published next week.

CHMP statistics

Key figures from the September 2015 CHMP meeting are represented in the graphic below.1

More information on this, and all other outcomes of the CHMP’s September 2015 meeting, is available in the grid below.

CHMP September 2015

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1In addition to the opinions on new medicines, the CHMP also adopted a revised positive opinion for Kolbam (cholic acid) for the treatment of inborn errors in primary bile acid synthesis. The revised opinion follows the annulment on 11 June 2015 of the marketing authorisation for Kolbam in the European Union following a judgment of the General Court.

Positive recommendations on new medicines

Name of medicineBlincyto
International non-proprietary name (INN)blinatumomab
Marketing-authorisation applicantAmgen Europe B.V.
Therapeutic indicationTreatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia
More informationSummary of opinion for Blincyto

 

Name of medicineCotellic
INNcobimetinib
Marketing-authorisation applicantRoche Registration Ltd
Therapeutic indicationTreatment of metastatic melanoma
More informationSummary of opinion for Cotellic

   

Name of medicineElocta
INNefmoroctocog alfa
Marketing-authorisation applicantBiogen Idec Ltd
Therapeutic indicationTreatment of haemophilia A
More informationSummary of opinion for Elocta

 

Name of medicineEntresto
INNsacubitril / valsartan
Marketing-authorisation applicantNovartis Europharm Ltd
Therapeutic indicationTreatment of heart failure (NYHA class II-IV)
More information

Summary of opinion for Entresto

 

Press release: New medicine to treat heart failure recommended for approval

 

Name of medicineGenvoya
INNelvitegravir, cobicitat, emtricitabine, tenofovir alafenamide
Marketing-authorisation applicantGilead Sciences International Ltd
Therapeutic indicationTreatment of Human Immunodeficiency Virus (HIV) infection
More informationSummary of opinion for Genvoya

  

Name of medicineIonsys
INNfentanyl
Marketing-authorisation applicantIncline Therapeutics Europe Ltd
Therapeutic indicationTreatment of post-operative pain
More informationSummary of opinion for Ionsys

  

Name of medicineKyprolis
INNcarfilzomib
Marketing-authorisation applicantAmgen Europe B.V.
Therapeutic indicationTreatment of multiple myeloma
More information

Summary of opinion for Kyprolis

 

Press release: New treatment option for patients with rare blood cancer

 

Name of medicineNucala
INNmepolizumab
Marketing-authorisation applicantGlaxoSmithKline Trading Services
Therapeutic indicationTreatment of asthma
More informationSummary of opinion for Nucala

 

Name of medicineNumient
INNlevodopa / carbidopa
Marketing-authorisation applicantImpax Laboratories Netherlands BV
Therapeutic indicationTreatment of Parkinson's disease
More informationSummary of opinion for Numient

  

Name of medicineOrkambi
INNlumacaftor / ivacaftor
Marketing-authorisation applicantVertex Pharmaceuticals (U.K.) Ltd
Therapeutic indicationTreatment of cystic fibrosis
More informationSummary of opinion for Orkambi

 

Name of medicinePraxbind
INNidarucizumab
Marketing-authorisation applicantBoehringer Ingelheim International GmbH
Therapeutic indicationPrevention and treatment of dabigatran associated haemorrhage
More information

Summary of opinion for Praxbind

 

Press release: EMA fast-tracks antidote to anticoagulant Pradaxa

   

Name of medicineRavicti
INNglycerol phenylbutyrate
Marketing-authorisation applicantHorizon Therapeutics Limited
Therapeutic indicationTreatment of patients with urea cycle disorders
More informationSummary of opinion for Ravicti

 

Positive recommendations on new informed-consent applications

Name of medicineEbymect
INNdapagliflozin / metformin
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationDiabetes mellitus
More informationSummary of opinion for Ebymect

 

Name of medicineEdistride
INNdapagliflozin
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationDiabetes mellitus
More informationSummary of opinion for Edistride

 

Positive recommendations on new generic medicines

Name of medicineAripiprazole Accord
INNaripiprazole
Marketing-authorisation applicantAccord Healthcare Ltd
Therapeutic indicationTreatment of schizophrenia and treatment and prevention of manic episodes in bipolar I disorder
More informationSummary of opinion for Aripiprazole Accord

 

Name of medicineCiambra
INNpemetrexed
Marketing-authorisation applicantMenarini International Operations Luxembourg S.A.
Therapeutic indicationTreatment of malignant pleural mesothelioma and non-small cell lung cancer
More informationSummary of opinion for Ciambra

 

Name of medicineCinacalcet Mylan
INNcinacalcet
Marketing-authorisation applicantMylan S.A.S
Therapeutic indicationTreatment of hyperparathyroidism and parathyroid carcinoma
More informationSummary of opinion for Cinacalcet Mylan

 

Name of medicinePemetrexed Hospira
INNpemetrexed
Marketing-authorisation applicantHospira UK Limited
Therapeutic indicationTreatment of malignant pleural mesothelioma and non-small cell lung cancer (excluding predominantly squamous cell histology)
More informationSummary of opinion for Pemetrexed Hospira

 

Name of medicinePemetrexed medac
INNpemetrexed
Marketing-authorisation applicantmedac Gesellschaft fur klinische Spezialpraparate mbH
Therapeutic indicationTreatment of malignant pleural mesothelioma and non-small cell lung cancer
More informationSummary of opinion for Pemetrexed medac

  

Positive recommendations on extensions of therapeutic indications

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

 

Name of medicineGilenya
INNfingolimod
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion for Gilenya

 

Name of medicineKalydeco
INNivacaftor
Marketing-authorisation holderVertex Pharmaceuticals (U.K.) Ltd
More informationSummary of opinion for Kalydeco

 

Name of medicineOpdivo
INNnivolumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More informationSummary of opinion for Opdivo

  

Name of medicineRebetol
INNribavirin
Marketing-authorisation holderMerck Sharp & Dohme Limited
More informationSummary of opinion for Rebetol

 

Name of medicineVidaza
INNazacitidine
Marketing-authorisation holderCelgene Europe Limited
More informationSummary of opinion for Vidaza

  

Other opinion

Name of medicineKolbam
INNcholic acid
Marketing-authorisation applicantRetrophin Europe Ltd
Therapeutic indicationTreatment of inborn errors of primary bile acid synthesis
More informationSummary of opinion for Kolbam

 

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
Start of Community reviews
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Organisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

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