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

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28/06/2013

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 medicineCholib
International non-proprietary name (INN)fenofibrate / simvastatine
Marketing-authorisation applicantAbbott Healthcare Products Ltd
Therapeutic indicationAdjunctive therapy to reduce triglycerides and increase high-density-lipoprotein-cholesterol levels
More informationSummary of opinion for Cholib

 

Name of medicineEvarrest
INNhuman fibrinogen / human thrombin
Marketing-authorisation applicantOmrix Biopharmaceuticals N.V.
Therapeutic indicationTreatment of haemostasis and as an adjunct to haemostasis in bleeding
More informationSummary of opinion for Evarrest

 

Name of medicineInflectra
INNinfliximab
Marketing-authorisation applicantHospira UK Ltd
Therapeutic indicationTreatment of rheumatoid arthritis, adult and paediatric Crohn’s disease, adult and paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis
More information

Summary of opinion for Inflectra
 

Press release: European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars

 

Name of medicineLemtrada
INNalemtuzumab
Marketing-authorisation applicantGenzyme Europe BV
Therapeutic indicationTreatment of multiple sclerosis
More informationSummary of opinion for Lemtrada

 

Name of medicineNexium Control
INNesomeprazole
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationShort-term treatment of reflux symptoms in adults
More informationSummary of opinion for Nexium Control

 

Name of medicineProcysbi
INNmercaptamine
Marketing-authorisation applicantRaptor Pharmaceuticals Europe BV
Therapeutic indicationManagement of cystinosis
More informationSummary of opinion for Procysbi

 

Name of medicineProvenge
INNautologous peripheral blood mononuclear cells activated with pap-gm-csf (sipuleucel-T)
Marketing-authorisation applicantDendreon UK Ltd
Therapeutic indicationTreatment of metastatic castration-resistant prostate cancer
More information

Summary of opinion for Provenge
 

Press release: European Medicines Agency recommends approval of fourth advanced therapy in Europe

 

Name of medicineRemsima
INNinfliximab
Marketing-authorisation applicantCelltrion Healthcare Hungary Kft
Therapeutic indicationTreatment of rheumatoid arthritis, adult and paediatric Crohn’s disease, adult and paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis
More information

Summary of opinion for Remsima
 

Press release: European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars

 

Name of medicineStivarga
INNregorafenib
Marketing-authorisation applicantBayer Pharma AG
Therapeutic indicationTreatment of metastatic colorectal cancer
More informationSummary of opinion for Stivarga

 

Name of medicineTafinlar
INNdabrafenib
Marketing-authorisation applicantGlaxoSmithKline Trading Services
Therapeutic indicationTreatment of unresectable or metastatic melanoma with a BRAF V600 mutation
More information

Summary of 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 medicineAubagio
INNteriflunomide
Marketing-authorisation applicantSanofi-aventis groupe
Therapeutic indicationTreatment of adult patients with relapsing-remitting multiple sclerosis
More informationSummary of opinion for Aubagio

 

Name of medicineLabazenit
INNbudesonide / salmeterol
Marketing-authorisation applicantLaboratoires SMB s.a.
Therapeutic indicationTreatment of asthma
More informationQuestions and answers on the refusal of the marketing authorisation for Labazenit

 

Positive recommendations on extensions of therapeutic indications

Name of medicineEvicel
INNhuman fibrinogen / human thrombin
Marketing-authorisation holderOmrix 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 informationSummary of opinion for Evicel

  

Name of medicineOnglyza
INNsaxagliptin
Marketing-authorisation holderBristol-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 informationSummary of opinion for Onglyza

   

Name of medicineTyverb
INNlapatinib
Marketing-authorisation holderGlaxo 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 informationSummary of opinion for Tyverb

 

Name of medicineVelcade
INNbortezomib
Marketing-authorisation holderJanssen-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 informationSummary of opinion for Velcade

  

Recommendations for new contraindications

Name of medicineAprovel
INNirbesartan
Marketing-authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
New contraindicationDo 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 informationSummary of opinion for Aprovel

 

Name of medicineCoAprovel
INNirbesartan / hydrochlorothiazide
Marketing-authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
New contraindicationCo-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 informationSummary of opinion for CoAprovel

 

Name of medicineCopalia
INNamlodipine / valsartan
Marketing-authorisation holderNovartis Europharm Ltd
New contraindicationConcomitant 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 informationSummary of opinion for Copalia

 

Name of medicineCopalia HCT
INNamlodipine / valsartan / hydrochlorothiazide
Marketing-authorisation holderNovartis Europharm Ltd
New contraindicationConcomitant 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 informationSummary of opinion for Copalia HCT

 

Name of medicineDafiro
INNamlodipine / valsartan
Marketing-authorisation holderNovartis Europharm Ltd
New contraindicationConcomitant 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 informationSummary of opinion for Dafiro

 

Name of medicineDafiro HCT
INNamlodipine / valsartan / hydrochlorothiazide
Marketing-authorisation holderNovartis Europharm Ltd
New contraindicationConcomitant 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 informationSummary of opinion for Dafiro HCT

 

Name of medicineExforge
INNamlodipine / valsartan
Marketing-authorisation holderNovartis Europharm Ltd
New contraindicationConcomitant 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 informationSummary of opinion for Exforge

 

Name of medicineExforge HCT
INNamlodipine / valsartan / hydrochlorothiazide
Marketing-authorisation holderNovartis Europharm Ltd
New contraindicationConcomitant 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 informationSummary of opinion for Exforge HCT

 

Name of medicineImprida
INNamlodipine / valsartan
Marketing-authorisation holderNovartis Europharm Ltd
New contraindicationConcomitant 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 informationSummary of opinion for Imprida

  

Name of medicineIrbesartan Zentiva
INNirbesartan
Marketing-authorisation holderSanofi-Aventis Groupe
New contraindicationDo 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 informationSummary of opinion for Irbesartan Zentiva

  

Name of medicineIrbesartan Hydrochlorothiazide Zentiva
INNirbesartan
Marketing-authorisation holderSanofi-Aventis Groupe
New contraindicationCo-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 informationSummary of opinion for Irbesartan Hydrochlorothiazide Zentiva

 

Name of medicineKarvea
INNibesartan
Marketing-authorisation holderSanofi-Aventis Groupe
New contraindicationDo 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 informationSummary of opinion for Karvea

 

Name of medicineKarvezide
INNirbesartan / hydrochlorothiazide
Marketing-authorisation holderSanofi-Aventis Groupe
New contraindicationCo-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 informationSummary of opinion for Karvezide

 

Other opinions

Name of medicineVectibix
INNpanitumumab
Marketing-authorisation holderAmgen Europe B.V.
Change to a therapeutic indicationVectibix 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 contraindicationThe combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.
More informationSummary of opinion for Vectibix

 

Withdrawal of applications

Name of medicineIXinity
INNtrenonacog alfa
More informationIXinity: Withdrawn application

 

Name of medicineOmontys
INNpeginesatide
More informationOmontys: Withdrawn application

 

Outcomes of arbitration procedures

Name of medicineOkrido
INNprednisolone sodium phosphate
Marketing-authorisation holderPharmapol Arzneimittelvertrieb GmbH
More informationOkrido: Article-29(4) referral

 

Outcomes of harmonisation procedures

Name of medicineSandimmun / Sandimmun Neoral
INNciclosporin
Marketing-authorisation holderNovartis
More informationQuestions and answers on Sandimmun, Sandimmun Neoral and associated names

  

Public-health recommendations on non-centrally authorised medicines

Name of medicineErgot derivatives
INNdihydroergocryptione / caffeine, dihydroergocristine, nicergoline, dihydroergotamine, dihydroergotoxine 
More informationNew restrictions on use of medicines containing ergot derivatives

 

Name of medicineIntravenous iron-containing medicines
INNferric carboxymaltose, iron sucrose, iron saccharose, iron hydroxy dextran, iron(III) isomaltoside 1000, iron gluconate (sodium ferric gluconate)
More informationNew recommendations to manage risk of allergic reactions with intravenous iron-containing medicines

 

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations / periodic safety update reports
Start of Community reviews
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Overview of invented names reviewed in June 2013 by the Name Review Group (NRG)
Organisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

 


Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.

Contact point:

Monika Benstetter
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu