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

News Human

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_highlights_September_2015.png

CHMP statistics: September 2015


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 medicine Blincyto
International non-proprietary name (INN) blinatumomab
Marketing-authorisation applicant Amgen Europe B.V.
Therapeutic indication Treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia
More information CHMP summary of opinion for Blincyto

 

Name of medicine Cotellic
INN cobimetinib
Marketing-authorisation applicant Roche Registration Ltd
Therapeutic indication Treatment of metastatic melanoma
More information CHMP summary of positive opinion for Cotellic

 

Name of medicine Elocta
INN efmoroctocog alfa
Marketing-authorisation applicant Biogen Idec Ltd
Therapeutic indication Treatment of haemophilia A
More information CHMP summary of positive opinion for Elocta

 

Name of medicine Entresto
INN sacubitril / valsartan
Marketing-authorisation applicant Novartis Europharm Ltd
Therapeutic indication Treatment of heart failure (NYHA class II-IV)
More information

CHMP summary of positive opinion Entresto

 

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

 

Name of medicine Genvoya
INN elvitegravir, cobicitat, emtricitabine, tenofovir alafenamide
Marketing-authorisation applicant Gilead Sciences International Ltd
Therapeutic indication Treatment of Human Immunodeficiency Virus (HIV) infection
More information CHMP summary of positive opinion for Genvoya

 

Name of medicine Ionsys
INN fentanyl
Marketing-authorisation applicant Incline Therapeutics Europe Ltd
Therapeutic indication Treatment of post-operative pain
More information

 

Name of medicine Kyprolis
INN carfilzomib
Marketing-authorisation applicant Amgen Europe B.V.
Therapeutic indication Treatment of multiple myeloma
More information

CHMP summary of positive opinion Kyprolis

 

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

 

Name of medicine Nucala
INN mepolizumab
Marketing-authorisation applicant GlaxoSmithKline Trading Services
Therapeutic indication Treatment of asthma
More information CHMP summary of positive opinion Nucala

 

Name of medicine Numient
INN levodopa / carbidopa
Marketing-authorisation applicant Impax Laboratories Netherlands BV
Therapeutic indication Treatment of Parkinson's disease
More information CHMP summary of positive opinion Numient

 

Name of medicine Orkambi
INN lumacaftor / ivacaftor
Marketing-authorisation applicant Vertex Pharmaceuticals (U.K.) Ltd
Therapeutic indication Treatment of cystic fibrosis
More information CHMP summary of positive opinion Orkambi

 

Name of medicine Praxbind
INN idarucizumab
Marketing-authorisation applicant Boehringer Ingelheim International GmbH
Therapeutic indication Prevention and treatment of dabigatran associated haemorrhage
More information

CHMP summary of positive opinion for Praxbind

 

Press release: EMA fast-tracks antidote to anticoagulant Pradaxa

 

Name of medicine Ravicti
INN glycerol phenylbutyrate
Marketing-authorisation applicant Horizon Therapeutics Limited
Therapeutic indication Treatment of patients with urea cycle disorders
More information CHMP summary of positive opinion for Ravicti

 

Positive recommendations on new informed-consent applications

Name of medicine Ebymect
INN dapagliflozin / metformin
Marketing-authorisation applicant AstraZeneca AB
Therapeutic indication Diabetes mellitus
More information CHMP summary of positive opinion Ebymect

 

Name of medicine Edistride
INN dapagliflozin
Marketing-authorisation applicant AstraZeneca AB
Therapeutic indication Diabetes mellitus
More information CHMP summary of positive opinion Edistride

 

Positive recommendations on new generic medicines

Name of medicine Aripiprazole Accord
INN aripiprazole
Marketing-authorisation applicant Accord Healthcare Ltd
Therapeutic indication Treatment of schizophrenia and treatment and prevention of manic episodes in bipolar I disorder
More information CHMP summary of positive opinion Aripiprazole Accord

 

Name of medicine Ciambra
INN pemetrexed
Marketing-authorisation applicant Menarini International Operations Luxembourg S.A.
Therapeutic indication Treatment of malignant pleural mesothelioma and non-small cell lung cancer
More information CHMP summary of positive opinion for Ciambra

 

Name of medicine Cinacalcet Mylan
INN cinacalcet
Marketing-authorisation applicant Mylan S.A.S
Therapeutic indication Treatment of hyperparathyroidism and parathyroid carcinoma
More information CHMP summary of positive opinion for Cinacalcet Mylan

 

Name of medicine Pemetrexed Hospira
INN pemetrexed
Marketing-authorisation applicant Hospira UK Limited
Therapeutic indication Treatment of malignant pleural mesothelioma and non-small cell lung cancer (excluding predominantly squamous cell histology)
More information CHMP summary of positive opinion Pemetrexed Hospira

 

Name of medicine Pemetrexed medac
INN pemetrexed
Marketing-authorisation applicant medac Gesellschaft fur klinische Spezialpraparate mbH
Therapeutic indication Treatment of malignant pleural mesothelioma and non-small cell lung cancer
More information CHMP summary of opinion for Pemetrexed medac

 

Positive recommendations on extensions of therapeutic indications

Name of medicine Eylea
INN aflibercept
Marketing-authorisation holder Bayer Pharma AG
More information CHMP post-authorisation summary of positive opinion for Eylea

 

Name of medicine Gilenya
INN fingolimod
Marketing-authorisation holder Novartis Europharm Ltd
More information CHMP post-authorisation summary of positive opinion for Gilenya

 

Name of medicine Kalydeco
INN ivacaftor
Marketing-authorisation holder Vertex Pharmaceuticals (U.K.) Ltd
More information CHMP post-authorisation summary of positive opinion for Kalydeco

 

Name of medicine Opdivo
INN nivolumab
Marketing-authorisation holder Bristol-Myers Squibb Pharma EEIG
More information CHMP post-authorisation summary of positive opinion for Opdivo

 

Name of medicine Rebetol
INN ribavirin
Marketing-authorisation holder Merck Sharp & Dohme Limited
More information CHMP post-authorisation summary of positive opinion for Rebetol

 

Name of medicine Vidaza
INN azacitidine
Marketing-authorisation holder Celgene Europe Limited
More information CHMP post-authorisation summary of positive opinion for Vidaza-II-30

 

Other opinion

Name of medicine Kolbam
INN cholic acid
Marketing-authorisation applicant Retrophin Europe Ltd
Therapeutic indication Treatment of inborn errors of primary bile acid synthesis
More information CHMP summary of positive opinion Kolbam

 

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