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

News Human

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

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

Other updates

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