Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2017

Eight medicines recommended for approval, including two medicines for chronic hepatitis C virus (HCV) infection

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval at its June meeting.

The CHMP recommended granting marketing authorisations for Maviret (glecaprevir / pibrentasvir) and Vosevi (sofosbuvir / velpatasvir / voxilaprevir) for the treatment of chronic hepatitis C virus (HCV) infection. Both medicines were reviewed under the EU's accelerated assessment mechanism. For more information on these medicines, please see the joint press release in the grid below.

Two cancer medicines received a positive opinion from the CHMP: Kisqali (ribociclib) for the treatment of locally advanced or metastatic breast cancer and Fotivda (tivozanib) for the treatment of advanced renal cell carcinoma.

Mavenclad (cladribine) received a positive opinion for the treatment of relapsing forms of multiple sclerosis.

One biosimilar medicine was recommended for approval by the Committee: Imraldi (adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, paediatric Crohn's disease, ulcerative colitis and uveitis. A biosimilar medicine is a biological medicine that is highly similar to another biological medicine that is already authorised for use.

Two generic medicines received a positive opinion from the CHMP: Efavirenz / Emtricitabine / Tenofovir disoproxil Mylan (efavirenz / emtricitabine / tenofovir disoproxil) for the treatment of HIV infection and Nitisinone MendeliKABS (nitisinone) for the treatment of hereditary tyrosinemia type 1.

Request for re-examination of three CHMP recommendations

The applicants for Adlumiz (anamorelin hydrochloride), Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech (human IgG1 monoclonal antibody specific for human interleukin-1 alpha) and Masipro (masitinib) have requested re-examinations of the Committee's negative opinions for these medicines adopted at the May 2017 meeting. The CHMP will now re-examine these opinions and issue final opinions.

For more information on these negative opinions, please see the questions-and-answers documents in the grid below.

Nine recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Faslodex, Harvoni, Kaletra, Mimpara, Orencia, Soliris, SonoVue, Stivarga and Victoza.

Withdrawals of applications

Applications for initial marketing authorisations for Elmisol (levamisole) and Zafiride (NGR-human tumour necrosis factor alpha) have been withdrawn.

Elmisol was intended to be used to treat nephrotic syndrome, a kidney disease. Zafiride was to treat patients with advanced malignant pleural mesothelioma, a cancer of the lining of the lungs usually caused by exposure to asbestos.

Questions-and-answers documents on these withdrawals are available in the grid below.

Outcome of review on Symbioflor 2

The CHMP has concluded that Symbioflor 2 can continue to be used for the treatment of irritable bowel syndrome in adults. However, the medicine should no longer be used more widely to treat functional gastrointestinal disorders, a group of disorders with a variety of causes that may require different treatment approaches. For more information, please see the public health communication in the grid below.

Agenda and minutes

The agenda of the June 2017 meeting is published on EMA's website. Minutes of the May 2017 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the June 2017 CHMP meeting are represented in the graphic below.

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Positive recommendations on new medicines

Name of medicine	Fotivda
INN	tivozanib
Marketing-authorisation applicant	Eusa Pharma
Therapeutic indication	Treatment of adult patients with advanced renal cell carcinoma
More information	Summary of opinion for Fotivda

Name of medicine	Kisqali
INN	ribociclib
Marketing-authorisation applicant	Novartis Europharm Ltd
Therapeutic indication	Treatment of breast cancer
More information	Summary of opinion Kisqali

Name of medicine	Mavenclad
INN	cladribine
Marketing-authorisation applicant	Merck Serono Europe Limited
Therapeutic indication	Treatment of relapsing forms of multiple sclerosis
More information	Summary of opinion for Mavenclad

Positive recommendations on new generic medicines

Name of medicine	Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
INN	efavirenz / emtricitabine / tenofovir disoproxil
Marketing-authorisation applicant	Mylan S.A.S
Therapeutic indication	Treatment of HIV infection
More information	Summary of opinion for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Name of medicine	Nitisinone MendeliKABS
INN	nitisinone
Marketing-authorisation applicant	MendeliKABS Europe Ltd
Therapeutic indication	Treatment of hereditary tyrosinemia type 1
More information	Summary of opinion for Nitisinone MendeliKABS

Positive recommendation on new biosimilar medicine

Name of medicine	Imraldi
INN	adalimumab
Marketing-authorisation applicant	Samsung Bioepis UK Limited (SBUK)
Therapeutic indication	Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, paediatric Crohn's disease, ulcerative colitis and uveitis
More information	Summary of opinion for Imraldi

Re-examination of recommendations for new medicines

Name of medicine	Adlumiz
INN	anamorelin hydrochloride
Marketing-authorisation applicant	Helsinn Birex Pharmaceuticals Ltd
Therapeutic indication	Treatment of anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer
More information	Questions and answers on Adlumiz

Name of medicine	Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
INN	human IgG1 monoclonal antibody specific for human interleukin-1 alpha
Marketing-authorisation applicant	XBiotech Germany GmbH
Therapeutic indication	Treatment of metastatic colorectal cancer
More information	Questions and answers on Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech

Name of medicine	Masipro
INN	masitinib
Marketing-authorisation applicant	AB Science
Therapeutic indication	Treatment of mastocytosis
More information	Questions and answers on Masipro

Positive recommendations on extensions of therapeutic indications

Name of medicine	Faslodex
INN	fulvestrant
Marketing-authorisation holder	AstraZeneca UK Ltd
More information	Summary of opinion for Faslodex

Name of medicine	Kaletra
INN	lopinavir / ritonavir
Marketing-authorisation holder	AbbVie Ltd.
More information	Summary of opinion for Kaletra

Name of medicine	Mimpara
INN	cinacalcet
Marketing-authorisation holder	Amgen Europe B.V.
More information	Summary of opinion for Mimpara

Name of medicine	Orencia
INN	abatacept
Marketing-authorisation holder	Bristol-Myers Squibb Pharma EEIG
More information	Summary of opinion for Orencia

Name of medicine	Soliris
INN	eculizumab
Marketing-authorisation holder	Alexion Europe SAS
More information	Summary of opinion for Soliris

Name of medicine	SonoVue
INN	sulphur hexafluoride
Marketing-authorisation holder	Bracco International B.V.
More information	Summary of opinion for SonoVue

Name of medicine	Stivarga
INN	regorafenib
Marketing-authorisation holder	Bayer Pharma AG
More information	Summary of opinion for Stivarga

Name of medicine	Victoza
INN	liraglutide
Marketing-authorisation holder	Novo Nordisk A/S
More information	Summary of opinion for Victoza

Public health recommendation

Outcome of arbitration procedure

Withdrawals of applications

Name of medicine	Elmisol
INN	levamisole
Marketing-authorisation holder	ACE Pharmaceuticals BV
More information	Questions and answers on Elmisol

Name of medicine	Zafiride
INN	NGR-human tumour necrosis factor alpha
Marketing-authorisation holder	MolMed SpA
More information	Questions and answers on Zafiride

Other updates

Recommendations on eligibility to PRIME scheme

Overview of (invented) names reviewed in May 2017 by the Name Review Group (NRG)

Scientific advice and protocol assistance

Start of Community reviews