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

 

London, UK, (June 26, 2015) – 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.

 

EMA.jpg

 

 

Positive recommendations on new medicines

 

Name of medicine

Farydak

International non-proprietary name (INN)

panobinostat

Marketing-authorisation applicant

Novartis Europharm Ltd

Therapeutic indication

Treatment 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 medicine

Kanuma

INN

sebelipase alfa

Marketing-authorisation applicant

Synageva BioPharma Ltd

Therapeutic indication

Treatment of lysosomal acid lipase deficiency

More information

Summary of opinion for Kanuma

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

 

Name of medicine

Odomzo

INN

sonidegib

Marketing-authorisation applicant

Novartis Europharm Ltd

Therapeutic indication

Treatment of basal cell carcinoma

More information

Summary of opinion for Odomzo

 

Name of medicine

Respreeza

INN

human alpha1-proteinase inhibitor

Marketing-authorisation applicant

CSL Behring GmbH

Therapeutic indication

Treatment of alpha1-proteinase inhibitor  deficiency

More information

Summary of opinion for Respreeza

 

Name of medicine

Strensiq

INN

asfotase alfa

Marketing-authorisation applicant

Alexion Europe SAS

Therapeutic indication

Treatment 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 medicine

Docetaxel Hospira UK Limited

INN

docetaxel 

Marketing-authorisation applicant

Hospira UK Limited

Therapeutic indication

Treatment of breast cancer, non small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer

More information

Summary of opinion for Docetaxel Hospira UK Limited

  

Name of medicine

Duloxetine Zentiva

INN

duloxetine

Marketing-authorisation applicant

Zentiva, k.s.

Therapeutic indication

Treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder

More information

Summary of opinion for Duloxetine Zentiva

 

Name of medicine

Pregabalin Accord

INN

pregabalin

Marketing-authorisation applicant

Accord Healthcare Limited

Therapeutic indication

Treatment of epilepsy and generalised anxiety disorder

More information

Summary of opinion for Pregabalin Accord

 

 

Positive recommendations on new hybrid medicines

 

Name of medicine

Aripiprazole Sandoz

INN

aripiprazole 

Marketing-authorisation applicant

Sandoz GmbH 

Therapeutic indication

Treatment of schizophrenia and treatment and prevention of manic episodes in bipolar I disorder 

More information

Summary of opinion for Aripiprazole Sandoz

 

Name of medicine

Raxone

INN

idebenone 

Marketing-authorisation applicant

Santhera Pharmaceuticals (Deutschland) GmbH 

Therapeutic indication

Treatment of Leber’s Hereditary Optic Neuropathy

More information

Summary of opinion for Raxone

 

 

Negative recommendation on new medicine    

 

Name of medicine

Heparesc

INN

human heterologous liver cells

More information

Questions and answers on Heparesc

 

 

Positive recommendation on new therapeutic indications   

 

Name of medicine

Humira

INN

adalimumab 

Marketing-authorisation holder

AbbVie Ltd 

More information

Summary of opinion for Humira

 

Press release: First medicine recommended for approval for hidradenitis suppurativa

  

Name of medicine

Levemir

INN

insulin detemir 

Marketing-authorisation holder

Novo Nordisk A/S 

More information

Summary of opinion for Levemir

    

Name of medicine

Perjeta

INN

pertuzumab 

Marketing-authorisation holder

Roche Registration Ltd 

More information

Summary of opinion for Perjeta

       

Name of medicine

Voncento

INN

human coagulation factor viii / human von willebrand factor 

Marketing-authorisation holder

CSL Behring GmbH 

More information

Summary of opinion for Voncento

    

 

Public health recommendation

 

Name of medicine

Adrenaline auto-injectors

INN

adrenaline (epinephrine)

More information

Better training tools recommended to support patients using adrenaline auto-injectors

  

 

Outcome of harmonisation procedure 

 

Name of medicine

Amoxil

INN

amoxicillin

Marketing-authorisation holder

GlaxoSmithKline

More information

Questions 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)

 

 


European Medicines Agency, 26.06.2015 (tB).

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