Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 2013

  • Email
  • Help

News

18/01/2013

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 2013

This page provides an overview of the opinions adopted at the January 2013 meeting of the CHMP and other important outcomes. 

In the table below, readers can view the main opinions adopted at the meeting, as well as information on referral procedures.

The new public-health communication document on the Agency’s recommendation to suspend Tredaptive, Pelzont and Trevaclyn combines the press release and question-and-answer document previously published following CHMP meetings.

The Agency publishes a new page following the CHMP meeting each month.


Positive recommendations on new medicines

Name of medicineBosulif
International non-proprietary name (INN)bosutinib
Marketing-authorisation applicantPfizer Ltd
Therapeutic indicationTreatment of chronic myelogenous leukaemia
More informationSummary of opinion for Bosulif

 

Name of medicineJetrea
INNocriplasmin
Marketing-authorisation applicantThromboGenics NV
Therapeutic indicationTreatment of symptomatic vitreomacular adhesion
More information

Summary of opinion for Jetrea

 

Press release: European Medicines Agency recommends approval of medicine for treatment of vitreomacular traction

 

Negative recommendation on new medicine

Name of medicineRaxone
INNidebenone
Marketing-authorisation applicantSanthera Pharmaceuticals (Deutschland) GmbH
Therapeutic indicationTreatment of Leber's hereditary optic neuropathy
More informationQuestions and answers on the refusal of the marketing authorisation for Raxone

 

Positive recommendations on new generic medicines

Name of medicineActelsar HCT
INNtelmisartan / hydrochlorothiazide
Marketing-authorisation applicantActavis Group PTC
Therapeutic indicationTreatment of essential hypertension
More informationSummary of opinion for Actelsar HCT

 

Name of medicineMaruxa
INNmemantine
Marketing-authorisation applicantKrka dd Novo mesto
Therapeutic indicationTreatment of Alzheimer's disease
More informationSummary of opinion for Maruxa

 

Name of medicineTolucombi
INNtelmisartan / hydrochlorothiazide
Marketing-authorisation applicantKrka dd Novo mesto
Therapeutic indicationTreatment of essential hypertension
More informationSummary of opinion for Tolucombi

 

Positive recommendations on extensions of therapeutic indications

Name of medicineHumira
INNadalimumab
Marketing-authorisation holderAbbott Laboratories Ltd
Change to a therapeutic indication
(changes in bold)

Polyarticular juvenile idiopathic arthritis

 

Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged 2 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Humira has not been studied in children aged less than 2 years.

 

Detailed conditions for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

More informationSummary of opinion for Humira

 

Name of medicineIlaris
INNcanakinumab
Marketing-authorisation holderNovartis Europharm Ltd
Therapeutic indication
(changes in bold)

Cryopyrin-associated periodic syndromes

 

Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, including:
- Muckle-Wells syndrome (MWS);
- neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA), severe forms of familial cold auto-inflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.

 

Gouty arthritis

 

Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least three attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contra-indicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate (see section 5.1).

More informationSummary of opinion for Ilaris

 

Name of medicineKomboglyze
INNsaxagliptin / metformin hydrychloride
Marketing-authorisation holderBristol-Myers Squibb
Therapeutic indication
(changes in bold)

Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.

 

Komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.

 

Komboglyze is also indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when the maximally tolerated dose of both metformin and the sulphonylurea does not provide adequate glycaemic control.

More informationSummary of opinion for Komboglyze

 

Name of medicineOnglyza
INNsaxagliptin
Marketing-authorisation holderAstra Zeneca EEIG
Therapeutic indication
(changes in bold)

Onglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:

 

- as dual oral therapy in combination with:

- metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;
- a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control. in patients for whom use of metformin is considered inappropriate;
- a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;
 

- as triple oral therapy in combination with:

- metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;


- as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

More informationSummary of opinion for Onglyza

 

Name of medicinePegasys
INNpeginterferon alfa-2a
Marketing-authorisation holderRoche Registration Ltd
New indication

Paediatric patients five years of age and older

 

Pegasys in combination with ribavirin is indicated for the treatment of chronic hepatitis C in treatment-naïve children and adolescents five years of age and older, who are positive for serum hepatitis-C-virus (HCV) RNA.

 

When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case-by-case basis (see section 4.4).

More informationSummary of opinion for Pegasys


Outcome of arbitration procedure

Name of medicineKantos Master and associated names
INNbeclometasone dipropionate / formoterol fumarate
Marketing-authorisation holderChiesi Farmaceutici S.p.A
More informationQuestions and answers on Kantos Master and associated names



Withdrawals of applications

Name of medicineLoulla
INNmercaptopurine
More informationQuestions and answers on the withdrawal of the marketing authorisation application for Loulla


 

Name of medicineMemantine FGK
INNmemantine
More informationQuestions and answers on the withdrawal of the marketing authorisation application for Memantine FGK



Public-health communication

European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn



Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
Start of Community reviews
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Overview of invented names reviewed in January 2012 by the Name Review Group (NRG)
Organisational matters

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