Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2013

This page provides an overview of the opinions adopted at the June 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

In one of the busiest CHMP meetings of 2013 so far, the Committee recommended 10 new medicines for approval, including the first two monoclonal-antibody biosimilars, and a new advanced-therapy medicine. These medicines are intended for patients suffering from diseases including cancer, multiple sclerosis and other auto-immune diseases.

Ten new medicines recommended for approval

The CHMP recommended granting of marketing authorisations for the first two monoclonal-antibody biosimilars. Remsima and Inflectra are recommended for authorisation in the same indications as Remicade (infliximab), a monoclonal antibody that has been authorised in the European Union (EU) since 1999. For more information, please see the press release in the table below.

Three medicines to treat cancer received positive opinions from the CHMP: Provenge, a cell-based therapy for the treatment of metastatic castrate-resistant prostate cancer, which is also the fourth advanced therapy medicinal product to be recommended for marketing authorisation by the CHMP; Tafinlar, for the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation; and Stivarga for the treatment of metastatic colorectal cancer. Please see the press releases on Provenge and Tafinlar in the table below.

The CHMP gave positive recommendations for the approval of Procysbi for the management of cystinosis and Lemtrada for the treatment of multiple sclerosis.

The Committee also recommended the granting of a marketing authorisation for Cholib as adjunctive therapy to diet and exercise, to reduce triglycerides and increase high-density-lipoprotein (HDL)-cholesterol levels in adults with mixed dyslipidaemia with high cardiovascular risk, Nexium Control for the short-term treatment of reflux symptoms in adults, and Evarrest for the treatment of haemostasis, and as an adjunct to haemostasis.

Re-examination of two initial recommendations for marketing authorisation

The CHMP adopted a positive re-examination opinion for Aubagio, revising its previous opinion not to grant new-active-substance status to the medicine at its March 2013 meeting.

The CHMP adopted a final negative opinion following the re-examination of Labazenit.

Four recommendations for extensions of indications

The CHMP recommended an extension of the existing indications for Evicel, Onglyza, Tyverb and Velcade.

Outcome of two safety reviews

The Committee also issued recommendations on ergot-derivative-containing products and iron-containing intravenous products.

Withdrawals

Question-and-answer documents on the withdrawal of marketing authorisation applications for Ixinity and Omontys are published below.

More information on these and all other outcomes of the CHMP June 2013 meeting is available in the table below.

Positive recommendations on new medicines

Name of medicine	Cholib
International non-proprietary name (INN)	fenofibrate / simvastatine
Marketing-authorisation applicant	Abbott Healthcare Products Ltd
Therapeutic indication	Adjunctive therapy to reduce triglycerides and increase high-density-lipoprotein-cholesterol levels
More information	CHMP summary of positive opinion for Cholib

Name of medicine	Evarrest
INN	human fibrinogen / human thrombin
Marketing-authorisation applicant	Omrix Biopharmaceuticals N.V.
Therapeutic indication	Treatment of haemostasis and as an adjunct to haemostasis in bleeding
More information	CHMP summary of positive opinion for Evarrest

Name of medicine	Inflectra
INN	infliximab
Marketing-authorisation applicant	Hospira UK Ltd
Therapeutic indication	Treatment of rheumatoid arthritis, adult and paediatric Crohn's disease, adult and paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis
More information	CHMP summary of positive opinion for Inflectra Press release: European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars

Name of medicine	Lemtrada
INN	alemtuzumab
Marketing-authorisation applicant	Genzyme Europe BV
Therapeutic indication	Treatment of multiple sclerosis
More information	CHMP summary of positive opinion for Lemtrada

Name of medicine	Nexium Control
INN	esomeprazole
Marketing-authorisation applicant	AstraZeneca AB
Therapeutic indication	Short-term treatment of reflux symptoms in adults
More information	CHMP summary of positive opinion for Nexium Control

Name of medicine	Procysbi
INN	mercaptamine
Marketing-authorisation applicant	Raptor Pharmaceuticals Europe BV
Therapeutic indication	Management of cystinosis
More information	CHMP summary of positive opinion for Procysbi

Name of medicine	Provenge
INN	autologous peripheral blood mononuclear cells activated with pap-gm-csf (sipuleucel-T)
Marketing-authorisation applicant	Dendreon UK Ltd
Therapeutic indication	Treatment of metastatic castration-resistant prostate cancer
More information	CHMP summary of positive opinion for Provenge Press release: European Medicines Agency recommends approval of fourth advanced therapy in Europe

Name of medicine	Remsima
INN	infliximab
Marketing-authorisation applicant	Celltrion Healthcare Hungary Kft
Therapeutic indication	Treatment of rheumatoid arthritis, adult and paediatric Crohn's disease, adult and paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis
More information	CHMP summary of positive opinion for Remsima Press release: European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars

Name of medicine	Stivarga
INN	regorafenib
Marketing-authorisation applicant	Bayer Pharma AG
Therapeutic indication	Treatment of metastatic colorectal cancer
More information	CHMP summary of positive opinion for Stivarga

Name of medicine	Tafinlar
INN	dabrafenib
Marketing-authorisation applicant	GlaxoSmithKline Trading Services
Therapeutic indication	Treatment of unresectable or metastatic melanoma with a BRAF V600 mutation
More information	CHMP summary of positive opinion for Tafinlar Press release: European Medicines Agency recommends approval of Tafinlar for the treatment of metastatic melanoma

Re-examinations of initial recommendations for marketing authorisation

Name of medicine	Aubagio
INN	teriflunomide
Marketing-authorisation applicant	Sanofi-aventis groupe
Therapeutic indication	Treatment of adult patients with relapsing-remitting multiple sclerosis
More information	CHMP summary of positive opinion for Aubagio

Name of medicine	Labazenit
INN	budesonide / salmeterol
Marketing-authorisation applicant	Laboratoires SMB s.a.
Therapeutic indication	Treatment of asthma
More information	Questions and answers on the refusal of the marketing authorisation for Labazenit - Outcome of re-examination

Positive recommendations on extensions of therapeutic indications

Name of medicine	Evicel
INN	human fibrinogen / human thrombin
Marketing-authorisation holder	Omrix Biopharmaceuticals S.A.
Change to a therapeutic indication (changes in bold)	Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. Evicel is also indicated as suture support for haemostasis in vascular surgery and for suture-line sealing in dura-mater closure.
More information	CHMP post-authorisation summary of positive opinion for Evicel

Name of medicine	Onglyza
INN	saxagliptin
Marketing-authorisation holder	Bristol-Myers Squibb /AstraZeneca EEIG
New indication	Onglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control: as monotherapy - in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance
More information	CHMP post-authorisation summary of positive opinion for Onglyza

Name of medicine	Tyverb
INN	lapatinib
Marketing-authorisation holder	Glaxo Group Limited
Change to a therapeutic indication (changes in bold)	Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2): - in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1); - in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1); - in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (see section 5.1). No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.
More information	CHMP post-authorisation summary of positive opinion for Tyverb

Name of medicine	Velcade
INN	bortezomib
Marketing-authorisation holder	Janssen-Cilag International NV
New therapeutic indication	Velcade in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic-stem-cell transplantation.
More information	CHMP post-authorisation summary of positive opinion for Velcade

Recommendations for new contraindications

Name of medicine	Aprovel
INN	irbesartan
Marketing-authorisation holder	Sanofi Pharma Bristol-Myers Squibb SNC
New contraindication	Do not co-administer Aprovel with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (glomerular filtration rate (GFR) 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for Aprovel

Name of medicine	CoAprovel
INN	irbesartan / hydrochlorothiazide
Marketing-authorisation holder	Sanofi Pharma Bristol-Myers Squibb SNC
New contraindication	Co-administration of CoAprovel with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (glomerular filtration rate (GFR) 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for CoAprovel

Name of medicine	Copalia
INN	amlodipine / valsartan
Marketing-authorisation holder	Novartis Europharm Ltd
New contraindication	Concomitant use of angiotensin-receptor antagonists (ARBs) - including valsartan - or of angiotensin-converting-enzyme (ACE) inhibitors with aliskiren in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for Copalia

Name of medicine	Copalia HCT
INN	amlodipine / valsartan / hydrochlorothiazide
Marketing-authorisation holder	Novartis Europharm Ltd
New contraindication	Concomitant use of angiotensin-receptor antagonists (ARBs) - including valsartan - or of angiotensin-converting-enzyme (ACE) inhibitors with aliskiren in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for Copalia HCT

Name of medicine	Dafiro
INN	amlodipine / valsartan
Marketing-authorisation holder	Novartis Europharm Ltd
New contraindication	Concomitant use of angiotensin-receptor antagonists (ARBs) - including valsartan - or of angiotensin-converting-enzyme (ACE) inhibitors with aliskiren in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for Dafiro

Name of medicine	Dafiro HCT
INN	amlodipine / valsartan / hydrochlorothiazide
Marketing-authorisation holder	Novartis Europharm Ltd
New contraindication	Concomitant use of angiotensin-receptor antagonists (ARBs) - including valsartan - or of angiotensin-converting-enzyme (ACE) inhibitors with aliskiren in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for Dafiro HCT

Name of medicine	Exforge
INN	amlodipine / valsartan
Marketing-authorisation holder	Novartis Europharm Ltd
New contraindication	Concomitant use of angiotensin-receptor antagonists (ARBs) - including valsartan - or of angiotensin-converting-enzyme (ACE) inhibitors with aliskiren in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for Exforge

Name of medicine	Exforge HCT
INN	amlodipine / valsartan / hydrochlorothiazide
Marketing-authorisation holder	Novartis Europharm Ltd
New contraindication	Concomitant use of angiotensin-receptor antagonists (ARBs) - including valsartan - or of angiotensin-converting-enzyme (ACE) inhibitors with aliskiren in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for Exforge HCT

Name of medicine	Imprida
INN	amlodipine / valsartan
Marketing-authorisation holder	Novartis Europharm Ltd
New contraindication	Concomitant use of angiotensin-receptor antagonists (ARBs) - including valsartan - or of angiotensin-converting-enzyme (ACE) inhibitors with aliskiren in patients with diabetes mellitus or renal impairment (GFR 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for Imprida

Name of medicine	Irbesartan Zentiva
INN	irbesartan
Marketing-authorisation holder	Sanofi-Aventis Groupe
New contraindication	Do not co-administer Irbesartan Zentiva with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (glomerular filtration rate (GFR) 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for Irbesartan Zentiva

Name of medicine	Irbesartan Hydrochlorothiazide Zentiva
INN	irbesartan
Marketing-authorisation holder	Sanofi-Aventis Groupe
New contraindication	Co-administration of Irbesartan Hydrochlorothiazide Zentiva with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (glomerular filtration rate (GFR) 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for Irbesartan Hydrochlorothiazide Zentiva

Name of medicine	Karvea
INN	ibesartan
Marketing-authorisation holder	Sanofi-Aventis Groupe
New contraindication	Do not co-administer Karvea with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (glomerular filtration rate (GFR) 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for Karvea

Name of medicine	Karvezide
INN	irbesartan / hydrochlorothiazide
Marketing-authorisation holder	Sanofi-Aventis Groupe
New contraindication	Co-administration of Karvezide with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (glomerular filtration rate (GFR) 60 ml/min/1.73 m²).
More information	CHMP post-authorisation summary of positive opinion for Karvezide

Other opinions

Name of medicine	Vectibix
INN	panitumumab
Marketing-authorisation holder	Amgen Europe B.V.
Change to a therapeutic indication	Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): - in first-line in combination with FOLFOX; - in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan); - as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Change to contraindication	The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.
More information	CHMP post-authorisation summary of positive opinion for Vectibix

Withdrawal of applications

Name of medicine	IXinity
INN	trenonacog alfa
More information	IXinity: Withdrawn application

Name of medicine	Omontys
INN	peginesatide
More information	Omontys: Withdrawn application

Outcomes of arbitration procedures

Name of medicine	Okrido
INN	prednisolone sodium phosphate
Marketing-authorisation holder	Pharmapol Arzneimittelvertrieb GmbH
More information	Okrido: Article-29(4) referral

Outcomes of harmonisation procedures

Name of medicine	Sandimmun / Sandimmun Neoral
INN	ciclosporin
Marketing-authorisation holder	Novartis
More information	Questions and answers on Sandimmun, Sandimmun Neoral and associated names (ciclosporin, 10-, 25-, 50- and 100-mg capsules, 100-mg/ml oral solution and 50-mg/ml concentrate for solution for infusion)

Public-health recommendations on non-centrally authorised medicines

Name of medicine	Ergot derivatives
INN	dihydroergocryptione / caffeine, dihydroergocristine, nicergoline, dihydroergotamine, dihydroergotoxine
More information	New restrictions on use of medicines containing ergot derivatives

Name of medicine	Intravenous iron-containing medicines
INN	ferric carboxymaltose, iron sucrose, iron saccharose, iron hydroxy dextran, iron(III) isomaltoside 1000, iron gluconate (sodium ferric gluconate)
More information	New recommendations to manage risk of allergic reactions with intravenous iron-containing medicines