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

News 26/06/2015

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.

 June 2015

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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

PDF iconSummary 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 information PDF iconSummary of opinion for Odomzo

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

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

PDF iconSummary 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 information PDF iconSummary 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 information PDF iconSummary of opinion for Duloxetine Zentiva

Name of medicinePregabalin Accord
INNpregabalin
Marketing-authorisation applicantAccord Healthcare Limited
Therapeutic indicationTreatment of epilepsy and generalised anxiety disorder
More information PDF iconSummary 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 information PDF iconSummary of opinion for Aripiprazole Sandoz

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

Negative recommendation on new medicine

Name of medicineHeparesc
INNhuman heterologous liver cells
More information PDF iconQuestions and answers on Heparesc

Positive recommendation on new therapeutic indications

Name of medicineHumira
INNadalimumab
Marketing-authorisation holderAbbVie Ltd
More information

PDF iconSummary 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 information PDF iconSummary of opinion for Levemir

Name of medicinePerjeta
INNpertuzumab
Marketing-authorisation holderRoche Registration Ltd
More information PDF iconSummary of opinion for Perjeta

Name of medicineVoncento
INNhuman coagulation factor viii / human von willebrand factor
Marketing-authorisation holderCSL Behring GmbH
More information PDF iconSummary 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

PDF iconStart of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconOverview of invented names reviewed in May 2015 by the Name Review Group (NRG)
PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
PDF iconGuidelines and concept papers adopted
PDF iconOrganisational matters

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