Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 June 2014

This page provides an overview of the opinions adopted at the June 2014 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

Six new medicines recommended for approval

The CHMP has recommended granting a marketing authorisation for Daklinza (daclatasvir) in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults. Please see the press release in the grid below for more information.

Abasria (insulin glargine) received a positive opinion for a marketing authorisation for the treatment of diabetes mellitus. Abasria is the first biosimilar insulin to be recommended for marketing authorisation in the European Union.

Vizamyl (flutemetamol (¹⁸F)) was recommended for the visual detection of amyloid-beta neuritic plaques in the brain.

Triumeq (abacavir sulfate / dolutegravir sodium / lamivudine) received a positive opinion for a marketing authorisation for the treatment of human immunodeficiency virus (HIV) infection in adults and adolescents from 12 years of age weighing at least 40 kg.

The CHMP gave a positive recommendation for Velphoro (mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) for the control of serum phosphorus levels in patients with end-stage renal disease.

The Committee also recommended granting a marketing authorisation for Clopidogrel / Acetylsalicylic acid Teva (clopidogrel / acetylsalicylic acid) for the prevention of atherothrombotic events.

Positive opinion on Vantobra adopted by written procedure

In addition to the positive opinions for the six new medicines adopted at the June 2014 meeting, the EMA would also like to highlight the CHMP's recommendation to grant a marketing authorisation for the hybrid medicine Vantobra (tobramycin), adopted via written procedure on 2 June 2014.

Seven recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Avastin, Eliquis, Enbrel, Eylea, Isentress, Kalydeco and Stivarga.

Re-examination of negative opinion on extension of indication for Avastin requested

The marketing-authorisation holder for Avastin has requested a re-examination of the CHMP's negative opinion recommending the refusal of a change to the marketing authorisation for this medicine, adopted at its May 2014 meeting. The change concerned an extension of indication to add treatment of glioblastoma (an aggressive type of brain cancer). Upon receipt of the grounds of the request for re-examination, the CHMP will re-examine this opinion and issue a final opinion.

Withdrawals of applications

The applications for marketing authorisation for Faldaprevir Boehringer Ingelheim (faldaprevir), and for an extension of indication for Tasigna (nilotinib) have been withdrawn. For more information, please see question-and-answer documents in the grid below.

Agenda and minutes

The agenda of the June 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the July CHMP meeting. Minutes of the May 2014 CHMP meeting will be published next week.

CHMP statistics

Key figures from the June 2014 CHMP meeting are represented in the graphic below. The total number of positive new opinions includes the hybrid medicine Vantobra, which was adopted by the Committee by written procedure in June 2014.

Positive recommendations on new medicines

Name of medicine	Daklinza
International non-proprietary name (INN)	daclatasvir
Marketing-authorisation applicant	Bristol-Myers Squibb Pharma EEIG
Therapeutic indication	Treatment of chronic hepatitis C virus (HCV)
More information
	Press release: European Medicines Agency recommends approval of Daklinza in chronic hepatitis C

Name of medicine	Triumeq
INN	abacavir sulfate / dolutegravir sodium / lamivudine
Marketing-authorisation applicant	ViiV Healthcare Uk Limited
Therapeutic indication	Treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age weighing at least 40 kg
More information	CHMP summary of positive opinion for Triumeq

Name of medicine	Velphoro
INN	mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches
Marketing-authorisation applicant	Vifor Fresenius Medical Care Renal Pharma France
Therapeutic indication	Indicated for the control of serum phosphorus levels in patients with end-stage renal disease
More information	CHMP summary of positive opinion for Velphoro

Name of medicine	Vizamyl
INN	flutemetamol (¹⁸F)
Marketing-authorisation applicant	GE Healthcare Ltd
Therapeutic indication	Indicated for the visual detection of amyloid-beta neuritic plaques in the brain
More information	CHMP summary of positive opinion for Vizamyl

Name of medicine	Clopidogrel / Acetylsalicylic acid Teva
INN	clopidogrel / acetylsalicylic acid
Marketing-authorisation applicant	Teva Pharma B.V.
Therapeutic indication	Prevention of atherothrombotic events
More information	CHMP summary of positive opinion for Clopidogrel / Acetylsalicylic acid Teva

Recommendation for new biosimilar medicine

Name of medicine	Abasria
INN	insulin glargine
Marketing-authorisation applicant	Eli Lilly Regional Operations GmbH
Therapeutic indication	Treatment of diabetes mellitus
More information	CHMP summary of positive opinion for Abasria

Positive recommendations on new therapeutic indications

Name of medicine	Avastin
INN	bevacizumab
Marketing-authorisation applicant	Roche Registration Ltd
More information	CHMP post-authorisation summary of positive opinion for Avastin

Name of medicine	Eliquis
INN	apixaban
Marketing-authorisation applicant	Bristol-Myers Squibb / Pfizer EEIG
More information	CHMP post-authorisation summary of positive opinion for Eliquis

Name of medicine	Enbrel
INN	etanercept
Marketing-authorisation applicant	Pfizer Ltd
More information	CHMP post-authorisation summary of positive opinion for Enbrel

Name of medicine	Eylea
INN	aflibercept
Marketing-authorisation applicant	Bayer Pharma AG
More information	CHMP post-authorisation summary of positive opinion for Eylea

Name of medicine	Isentress
INN	raltegravir
Marketing-authorisation applicant	Merck Sharp & Dohme Ltd
More information	CHMP post-authorisation summary of positive opinion for Isentress

Name of medicine	Kalydeco
INN	ivacaftor
Marketing-authorisation applicant	Vertex Pharmaceuticals (UK) Ltd
More information	CHMP post-authorisation summary of positive opinion for Kalydeco

Name of medicine	Stivarga
INN	regorafenib
Marketing-authorisation applicant	Bayer Pharma AG
More information	CHMP post-authorisation summary of positive opinion for Stivarga

Outcome of arbitration procedure

Name of medicine	Seasonique and associated names
INN	levonogestrel 150 ?g and ethinylestradiol 30 ?g / 10 ?g
More information	Questions and answers on Seasonique and associated names

Outcomes of harmonisation procedures

Name of medicine	Sandostatin and associated names
INN	octreotide acetate
More information	Questions and answers on Sandostatin and associated names

Name of medicine	Sandostatin LAR and associated names
INN	octreotide acetate
More information	Questions and answers on Sandostatin LAR and associated names

Withdrawal of application

Name of medicine	Faldaprevir Boehringer Ingelheim
INN	faldaprevir
More information	Questions and answers on the withdrawal of the marketing authorisation application for Faldaprevir Boehringer Ingelheim (faldaprevir)

Withdrawal of application for extension of therapeutic indication

Name of medicine	Tasigna
INN	nilotinib
Marketing-authorisation applicant	Novartis Europharm Ltd
More information	Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Tasigna (nilotinib)