Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2015

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26/06/2015

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2015

Ten new medicines, including two enzyme replacement therapies for rare diseases, recommended for approval

Ten new medicines have been recommended for approval at the June 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP).

Two enzyme replacement therapies for the treatment of rare genetic diseases received a positive opinion from the CHMP: Kanuma (sebelipase alfa) for the treatment of lysosomal acid lipase deficiency, and Strensiq (asfotase alfa), the first therapy for the bone disease hypophosphatasia that started in childhood. For more information on these two enzyme replacement therapies, both of which have an orphan designation, please see the press releases in the grid below.

The CHMP also recommended granting a marketing authorisation for Farydak (panobinostat) for the treatment of relapsed and/or refractory multiple myeloma. Farydak is the first cancer medicine that targets enzymes known as histone deacetylases. Farydak has an orphan designation. For more information on Farydak, please see the press release in the grid below.

Odomzo (sonidegib) received a position opinion from the CHMP for the treatment of basal cell carcinoma.

The CHMP also recommended Respreeza (human alpha1-proteinase inhibitor) for the treatment of alpha1-proteinase inhibitor deficiency.

Three generic medicines received positive opinions from the CHMP: Docetaxel Hospira UK Limited (docetaxel) for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer, Duloxetine Zentiva (duloxetine) for the treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder and Pregabalin Accord (pregabalin) for the treatment of epilepsy and generalised anxiety disorder.

Two ‘hybrid’ medicines received positive opinions from the Committee: Aripiprazole Sandoz (aripiprazole) for the treatment of schizophrenia and the prevention and treatment of manic episodes in bipolar 1 disorder, and Raxone (idebenone) for the treatment of visual impairment in patients with Leber’s hereditary optic neuropathy. Raxone has an orphan designation. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials carried out with the reference product and in part on new data.

Negative opinion on new medicine

The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for the advanced therapy medicinal product Heparesc (human heterologous liver cells). Heparesc was intended to be used for the treatment of certain urea cycle disorders.

Four recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Humira, Levemir, Perjeta and Voncento. For more information on the extension of indication for Humira, please see the press release in the grid below.

Outcome of review on adrenaline auto-injectors

The CHMP recommended several measures, including the introduction of educational material, to ensure that patients and carers use adrenaline auto-injectors successfully. An adrenaline auto-injectors are potentially life-saving treatments for anaphylaxis (severe allergic reactions) while the patient waits for emergency medical assistance. For more information on the outcome of this review, please see the public health communication in the grid below.

Agenda and minutes

The agenda of the June 2015 meeting is published on EMA’s website. The minutes of the meeting will be published during the week following the July CHMP meeting.

CHMP statistics

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

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

CHMP statistics: June 2015

Download image in PDF format

 

Positive recommendations on new medicines

Name of medicineFarydak
International non-proprietary name (INN)panobinostat
Marketing-authorisation applicantNovartis Europharm Ltd
Therapeutic indicationTreatment of multiple myeloma
More information

Summary of opinion for Farydak


Press release: First HDAC inhibitor for treatment of multiple myeloma recommended for approval in EU

  

Name of medicineKanuma
INNsebelipase alfa
Marketing-authorisation applicantSynageva BioPharma Ltd
Therapeutic indicationTreatment of lysosomal acid lipase deficiency
More informationSummary of opinion for Kanuma

Press release: EMA fast-tracks enzyme replacement therapy for lysosomal acid lipase deficiency

 

Name of medicineOdomzo
INNsonidegib
Marketing-authorisation applicantNovartis Europharm Ltd
Therapeutic indicationTreatment of basal cell carcinoma
More informationSummary of opinion for Odomzo

 

Name of medicineRespreeza
INNhuman alpha1-proteinase inhibitor
Marketing-authorisation applicantCSL Behring GmbH
Therapeutic indicationTreatment of alpha1-proteinase inhibitor  deficiency
More informationSummary of opinion for Respreeza

 

Name of medicineStrensiq
INNasfotase alfa
Marketing-authorisation applicantAlexion Europe SAS
Therapeutic indicationTreatment of paediatric-onset hypophosphatasia
More information

Summary of opinion for Strensiq

 

Press release: First treatment recommended for rare bone disease

    

Positive recommendations on new generic medicines

Name of medicineDocetaxel Hospira UK Limited
INNdocetaxel 
Marketing-authorisation applicantHospira UK Limited
Therapeutic indicationTreatment of breast cancer, non small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer
More informationSummary of opinion for Docetaxel Hospira UK Limited

  

Name of medicineDuloxetine Zentiva
INNduloxetine
Marketing-authorisation applicantZentiva, k.s.
Therapeutic indicationTreatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder
More informationSummary of opinion for Duloxetine Zentiva

 

Name of medicinePregabalin Accord
INNpregabalin
Marketing-authorisation applicantAccord Healthcare Limited
Therapeutic indicationTreatment of epilepsy and generalised anxiety disorder
More informationSummary of opinion for Pregabalin Accord

 

Positive recommendations on new hybrid medicines

Name of medicineAripiprazole Sandoz
INNaripiprazole 
Marketing-authorisation applicantSandoz GmbH 
Therapeutic indicationTreatment of schizophrenia and treatment and prevention of manic episodes in bipolar I disorder 
More informationSummary of opinion for Aripiprazole Sandoz

 

Name of medicineRaxone
INNidebenone 
Marketing-authorisation applicantSanthera Pharmaceuticals (Deutschland) GmbH 
Therapeutic indicationTreatment of Leber’s Hereditary Optic Neuropathy
More informationSummary of opinion for Raxone

 

Negative recommendation on new medicine    

Name of medicineHeparesc
INNhuman heterologous liver cells
More informationQuestions and answers on Heparesc

 

Positive recommendation on new therapeutic indications   

Name of medicineHumira
INNadalimumab 
Marketing-authorisation holderAbbVie Ltd 
More information

Summary of opinion for Humira

 

Press release: First medicine recommended for approval for hidradenitis suppurativa

  

Name of medicineLevemir
INNinsulin detemir 
Marketing-authorisation holderNovo Nordisk A/S 
More informationSummary of opinion for Levemir

    

Name of medicinePerjeta
INNpertuzumab 
Marketing-authorisation holderRoche Registration Ltd 
More informationSummary of opinion for Perjeta

       

Name of medicineVoncento
INNhuman coagulation factor viii / human von willebrand factor 
Marketing-authorisation holderCSL Behring GmbH 
More informationSummary of opinion for Voncento

    

Public health recommendation

Name of medicineAdrenaline auto-injectors
INNadrenaline (epinephrine)
More informationBetter training tools recommended to support patients using adrenaline auto-injectors

  

Outcome of harmonisation procedure 

Name of medicineAmoxil
INNamoxicillin
Marketing-authorisation holderGlaxoSmithKline
More informationQuestions and answers on Amoxil

 

Other updates

Start of Community reviews
Scientific advice and protocol assistance
Overview of invented names reviewed in May 2015 by the Name Review Group (NRG)
Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
Guidelines and concept papers adopted
Organisational matters

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