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

26 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

 

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	CHMP summary of positive 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	CHMP 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	CHMP summary of positive 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	CHMP summary of positive 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	CHMP summary of positive 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

 

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	CHMP summary of positive 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	CHMP summary of positive 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	CHMP summary of positive 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	CHMP summary of positive opinion for Raxone

 

Negative recommendation on new medicine

Name of medicine	Heparesc
INN	human heterologous liver cells
More information	Questions and answers on refusal of the marketing authorisation for Heparesc (human heterologous liver cells)

 

Positive recommendation on new therapeutic indications

Name of medicine	Humira
INN	adalimumab
Marketing-authorisation holder	AbbVie Ltd
More information	CHMP post-authorisation summary of positive 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	CHMP post-authorisation summary of positive opinion for Levemir

 

Name of medicine	Perjeta
INN	pertuzumab
Marketing-authorisation holder	Roche Registration Ltd
More information	CHMP post-authorisation summary of positive opinion for Perjeta

 

Name of medicine	Voncento
INN	human coagulation factor viii / human von willebrand factor
Marketing-authorisation holder	CSL Behring GmbH
More information	CHMP post-authorisation summary of positive 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 - CHMP meeting of 22-25 June 2015

Scientific advice and protocol assistance adopted during the CHMP meeting 22 – 25 June 2015

Overview of (invented) names reviewed in May 2015 by the Name Review Group (NRG) adopted at the CHMP meeting of 22-25 June 2015

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 22-25 June 2015

Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 22-25 June 2015

Guidelines and concept papers adopted during the CHMP meeting 22-25 June 2015

Organisational matters - CHMP meeting 22-25 June 2015