Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017

Eleven medicines recommended for approval, including five orphans

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

The CHMP recommended granting a marketing authorisation for Verkazia (ciclosporin), an orphan medicine to treat severe vernal keratoconjunctivitis in children and adolescents. This medicine was reviewed under EMA's accelerated assessment mechanism. For more information, please see the press release in the grid below.

Four other orphan medicines were recommended for approval by the Committee: Bavencio (avelumab) for the treatment of Merkel cell carcinoma; Lutathera (lutetium [¹⁷⁷Lu] oxodotreotide), for the treatment of gastro-entero-pancreatic neuroendocrine tumours; Rydapt (midostaurin), for the treatment of acute myeloid leukaemia, aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm and mast cell leukaemia; and Xermelo (telotristat ethyl), for the treatment of carcinoid syndrome.

Dupixent (dupilumab) received a positive opinion for the treatment of atopic dermatitis.

The CHMP adopted a positive opinion for Symtuza (darunavir / cobicistat / emtricitabine / tenofovir alafenamide) for the treatment of HIV infection.

Tecentriq (atezolizumab) received a positive opinion for the treatment of locally advanced or metastatic urothelial carcinoma and of non-small cell lung cancer.

Three generic medicines received a positive opinion from the CHMP: Entecavir Accord (entecavir) and Entecavir Mylan (entecavir), both for the treatment of chronic hepatitis B; and Lacosamide Accord (lacosamide), for the treatment of epilepsy.

Negative opinions on two new medicines

The CHMP adopted a negative opinion for Fanaptum (iloperidone). Fanaptum was expected to be used to treat schizophrenia.

The Committee also adopted a negative opinion for Onzeald (etirinotecan pegol). Onzeald was intended to be used to treat breast cancer with brain metastases.

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

Eight recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Bydureon, Gazyvaro, Humira, Keytruda, RoActemra, Signifor, Sovaldi and Vimpat.

Outcome of review on gadolinium contrast agents

The CHMP recommended restricting the use of some linear gadolinium agents used in magnetic resonance imaging (MRI) body scans and suspending the authorisations of others. For more information please see the public health communication in the grid below.

Re-examination of arbitration procedure

The applicant for Alcover 750 mg, 1250 mg, 1750 mg granules (sodium oxybate) has requested a re-examination of the CHMP's June 2017 opinion. Upon receipt of the grounds for the request, the CHMP will re-examine its opinion and issue a final recommendation.

Withdrawal of application

The application for an initial marketing authorisation for Infinia (alpha-1-antitrypsin) was withdrawn. This medicine was intended to be used for the treatment of adults with lung disease due to congenital deficiency of alpha-1-antitrypsin. A questions-and-answers document on this withdrawal is available in the grid below.

Agenda and minutes

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

CHMP statistics

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

CHMP statistics: July 2017

Positive recommendations on new medicines

Name of medicine	Bavencio
International non-proprietary name (INN)	avelumab
Marketing-authorisation applicant	Merck Serono Europe Ltd
Therapeutic indication	Treatment of metastatic Merkel cell carcinoma
More information	CHMP summary of positive opinion for Bavencio

Name of medicine	Dupixent
INN	dupilumab
Marketing-authorisation applicant	Sanofi-Aventis groupe
Therapeutic indication	Treatment of atopic dermatitis
More information	CHMP summary of positive opinion for Dupixent

Name of medicine	Lutathera
INN	lutetium (¹⁷⁷lu) oxodotreotide
Marketing-authorisation applicant	Advanced Accelerator Applications
Therapeutic indication	Treatment of well differentiated gastroenteropancreatic neuroendocrine tumours
More information	CHMP summary of positive opinion for Lutathera

Name of medicine	Rydapt
INN	midostaurin
Marketing-authorisation applicant	Novartis Europharm Ltd
Therapeutic indication	Treatment of acute myeloid leukaemia, aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm and mast cell leukaemia
More information	CHMP summary of positive opinion for Rydapt

Name of medicine	Symtuza
INN	darunavir / cobicistat / emtricitabine / tenofovir alafenamide
Marketing-authorisation applicant	Janssen-Cilag International N.V.
Therapeutic indication	Treatment of HIV infection
More information	CHMP summary of positive opinion for Symtuza

Name of medicine	Tecentriq
INN	atezolizumab
Marketing-authorisation applicant	Roche Registration Ltd
Therapeutic indication	Treatment of locally advanced or metastatic urothelial carcinoma and of non-small cell lung cancer
More information	CHMP summary of positive opinion for Tecentriq

Name of medicine	Verkazia
INN	ciclosporin
Marketing-authorisation applicant	Santen Oy
Therapeutic indication	Treatment of severe vernal keratoconjunctivitis
More information	CHMP summary of positive opinion for Verkazia Press release: New medicine for rare form of eye allergy in children and teenagers

Name of medicine	Xermelo
INN	telotristat ethyl
Marketing-authorisation applicant	Ipsen Pharma
Therapeutic indication	Treatment of carcinoid syndrome diarrhoea in combination with a somatostatin analogue
More information	CHMP summary of positive opinion for Xermelo

Positive recommendations on new generic medicines

Name of medicine	Entecavir Accord
INN	entecavir
Marketing-authorisation applicant	Accord Healthcare Ltd
Therapeutic indication	Treatment of chronic hepatitis B
More information	CHMP summary of positive opinion for Entecavir Accord

Name of medicine	Entecavir Mylan
INN	entecavir
Marketing-authorisation applicant	Mylan S.A.S.
Therapeutic indication	Treatment of chronic hepatitis B
More information	CHMP summary of positive opinion for Entecavir Mylan

Name of medicine	Lacosamide Accord
INN	lacosamide
Marketing-authorisation applicant	Accord Healthcare Ltd
Therapeutic indication	Treatment of epilepsy
More information	CHMP summary of positive opinion for Lacosamide Accord

Negative recommendations on new medicines

Name of medicine	Fanaptum
INN	iloperidone
Marketing-authorisation applicant	Vanda Pharmaceuticals Ltd
Therapeutic indication	Treatment of schizophrenia
More information	Questions and answers on the refusal of the marketing authorisation for Fanaptum (iloperidone)

Name of medicine	Onzeald
INN	etirinotecan pegol
Marketing-authorisation applicant	Nektar Therapeutics UK Ltd
Therapeutic indication	Treatment of advanced breast cancer which has spread to the brain
More information	Questions and answers on the refusal of the marketing authorisation for Onzeald (etirinotecan pegol)

Positive recommendations on extensions of therapeutic indications

Name of medicine	Bydureon
INN	exenatide
Marketing-authorisation holder	AstraZeneca AB
More information	CHMP post-authorisation summary of positive opinion for Bydureon

Name of medicine	Gazyvaro
INN	obinutuzumab
Marketing-authorisation holder	Roche Registration Ltd
More information	CHMP post-authorisation summary of positive opinion for Gazyvaro (II-16)

Name of medicine	Humira
INN	adalimumab
Marketing-authorisation holder	AbbVie Ltd
More information	CHMP post-authorisation summary of positive opinion for Humira (II-163)

Name of medicine	Keytruda
INN	pembrolizumab
Marketing-authorisation holder	Merck Sharp & Dohme Ltd
More information	CHMP post-authorisation summary of positive opinion for Keytruda

Name of medicine	RoActemra
INN	tocilizumab
Marketing-authorisation holder	Roche Registration Ltd
More information	CHMP post-authorisation summary of positive opinion for RoActemra (II-66)

Name of medicine	Signifor
INN	pasireotide
Marketing-authorisation holder	Novartis Europharm Ltd
More information	CHMP post-authorisation summary of positive opinion for Signifor (X-30-G)

Name of medicine	Sovaldi
INN	sofosbuvir
Marketing-authorisation holder	Gilead Sciences International Ltd
More information	CHMP post-authorisation summary of positive opinion for Sovaldi

Name of medicine	Vimpat
INN	lacosamide
Marketing-authorisation holder	UCB Pharma S.A.
More information	CHMP post-authorisation summary of positive opinion for Vimpat (II-65-G)

Public health recommendation

Name of medicine	Gadolinium-containing contrast agents
INN	gadobenic acid / gadobutrol / gadodiamide / gadopentetic acid / gadoteric acid / gadoteridol / gadoversetamide / gadoxetic acid
More information	EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans

Re-examination of arbitration procedure

Name of medicine	Alcover 750 mg, 1250 mg, 1750 mg granules
INN	sodium oxybate
Marketing-authorisation holder	D&A Pharma
More information	Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg)

Withdrawal of application

Name of medicine	Infinia
INN	alpha-1-antitrypsin
More information	Questions and answers on the withdrawal of the marketing authorisation application for Infinia (alpha-1-antitrypsin)

Other updates

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 17-20 July 2017

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

Scientific advice and protocol assistance adopted during the CHMP meeting 17 – 20 July 2017

Start of Community reviews