Omontys

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Questions and answers

On 28 June 2013, Takeda Global Research and Development Centre (Europe) officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Omontys, for the treatment of symptomatic anaemia associated with chronic kidney disease in adult patients undergoing dialysis.

What is Omontys?

Omontys is a medicine containing the active substance peginesatide. It was to be made available as a solution for injection.

What was Omontys expected to be used for?

Omontys was expected to be used to treat adults with symptomatic anaemia (low red-blood-cell counts) associated with chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly) who are undergoing dialysis (a blood clearance technique used in patients with kidney disease).

How is Omontys expected to work?

The active substance in Omontys, peginesatide, is expected to replace the action of erythropoietin, a natural hormone that stimulates the production of red blood cells from the bone marrow. Erythropoietin is normally produced by the kidneys. Patients with chronic kidney disease can suffer from anaemia because their kidneys do not produce enough of this hormone. Peginesatide is expected to attach to receptors for erythropoietin, thereby stimulating the production of red blood cells in the bone marrow.

What did the company present to support its application?

The company presented the results of two main studies involving 1,626 patients with chronic kidney disease undergoing dialysis, to assess the effectiveness of Omontys at maintaining red blood cell counts. In both studies, Omontys was compared with another medicine called epoetin. The main measure of effectiveness was the change in levels of haemoglobin (a protein found in red blood cells) between the start of the study and the evaluation period.

How far into the evaluation was the application when it was withdrawn?

The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions. The company had not yet responded to the last round of questions at the time of the withdrawal.

What was the recommendation of the CHMP at that time?

Based on the review of the data and the company’s responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Omontys could not have been approved. In particular, the CHMP was concerned by some supportive study results indicating that Omontys may increase the risk of death or heart and circulatory problems in patients treated for the first time compared with similar medicines for stimulating red-blood-cell production. The Committee was also concerned by the results of inspections indicating that the study data submitted might not be fully reliable. In addition, the CHMP was concerned by reports of serious hypersensitivity (allergic) reactions, including fatal reactions, in some patients given Omontys in the United States (US), which had led to the removal of Omontys from the US market in February 2013. Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Omontys did not outweigh its risks.

What were the reasons given by the company for withdrawing the application?

In its letter notifying the Agency of the withdrawal of application, the company stated that it would not be able to address the CHMP’s concerns regarding the hypersensitivity reactions seen in the US within the timetable for the application procedure as the investigation into the root cause was still ongoing.

The withdrawal letter is available under the 'All documents' tab.

What consequences does this withdrawal have for patients in clinical trials?

The company informed the CHMP that one clinical study was currently ongoing in patients with pure red-cell aplasia (where no red blood cells are produced) associated with chronic kidney disease. It informed the CHMP that recruitment of new patients had been halted (due to the risk of hypersensitivity after the first injection), but patients currently enrolled in this study had the option to continue receiving Omontys.

If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.

Name Language First published Last updated
Questions and answers on the withdrawal of the marketing authorisation application for Omontys (English only) 28/06/2013  

News

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 Summary of 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 Summary of 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

Summary of 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 Summary of 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 Summary of opinion for Nexium Control

 

Name of medicine Procysbi
INN mercaptamine
Marketing-authorisation applicant Raptor Pharmaceuticals Europe BV
Therapeutic indication Management of cystinosis
More information Summary of 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

Summary of 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

Summary of 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 Summary of 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

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 medicine Aubagio
INN teriflunomide
Marketing-authorisation applicant Sanofi-aventis groupe
Therapeutic indication Treatment of adult patients with relapsing-remitting multiple sclerosis
More information Summary of 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

 

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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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 Summary of 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

  

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

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

 

Key facts

Product details for Omontys
NameOmontys
Product numberEMEA/H/C/002600
Date of issue of marketing authorisation valid throughout the European Union (if applicable)
International non-proprietary name or common name

peginesatide

Active substancepeginesatide
Date of withdrawal28/06/2013
Company making the application

Takeda Global Research and Development Centre (Europe)

Withdrawal typeInitial authorisation
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

All documents

Name Language First published Last updated
Withdrawal assessment report for Omontys (English only) 10/09/2013  
Questions and answers on the withdrawal of the marketing authorisation application for Omontys (English only) 28/06/2013  
Withdrawal letter: Omontys (English only) 28/06/2013  

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

More information on Omontys