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 medicine	Bosulif
International non-proprietary name (INN)	bosutinib
Marketing-authorisation applicant	Pfizer Ltd
Therapeutic indication	Treatment of chronic myelogenous leukaemia
More information	CHMP summary of positive opinion for Bosulif

Name of medicine	Jetrea
INN	ocriplasmin
Marketing-authorisation applicant	ThromboGenics NV
Therapeutic indication	Treatment of symptomatic vitreomacular adhesion
More information	CHMP summary of positive opinion for Jetrea Press release: European Medicines Agency recommends approval of medicine for treatment of vitreomacular traction

Negative recommendation on new medicine

Name of medicine	Raxone
INN	idebenone
Marketing-authorisation applicant	Santhera Pharmaceuticals (Deutschland) GmbH
Therapeutic indication	Treatment of Leber's hereditary optic neuropathy
More information	Questions and answers on the refusal of the marketing authorisation for Raxone

Positive recommendations on new generic medicines

Name of medicine	Actelsar HCT
INN	telmisartan / hydrochlorothiazide
Marketing-authorisation applicant	Actavis Group PTC
Therapeutic indication	Treatment of essential hypertension
More information	CHMP summary of positive opinion for Actelsar HCT

Name of medicine	Maruxa
INN	memantine
Marketing-authorisation applicant	Krka dd Novo mesto
Therapeutic indication	Treatment of Alzheimer's disease
More information	CHMP summary of positive opinion for Maruxa

Name of medicine	Tolucombi
INN	telmisartan / hydrochlorothiazide
Marketing-authorisation applicant	Krka dd Novo mesto
Therapeutic indication	Treatment of essential hypertension
More information	CHMP summary of positive opinion for Tolucombi

Positive recommendations on extensions of therapeutic indications

Name of medicine	Humira
INN	adalimumab
Marketing-authorisation holder	Abbott 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 information	CHMP post-authorisation summary of positive opinion for Humira

Name of medicine	Ilaris
INN	canakinumab
Marketing-authorisation holder	Novartis 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 information	CHMP post-authorisation summary of positive opinion for Ilaris

Name of medicine	Komboglyze
INN	saxagliptin / metformin hydrychloride
Marketing-authorisation holder	Bristol-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 information	CHMP post-authorisation summary of positive opinion for Komboglyze

Name of medicine	Onglyza
INN	saxagliptin
Marketing-authorisation holder	Astra 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 information	CHMP post-authorisation summary of positive opinion for Onglyza

Name of medicine	Pegasys
INN	peginterferon alfa-2a
Marketing-authorisation holder	Roche 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 information	CHMP post-authorisation summary of positive opinion for Pegasys

Outcome of arbitration procedure

Name of medicine	Kantos Master and associated names
INN	beclometasone dipropionate / formoterol fumarate
Marketing-authorisation holder	Chiesi Farmaceutici S.p.A
More information	Questions and answers on Kantos Master and associated names (beclomethasone dipropionate / formoterol fumarate, inhaler)

Withdrawals of applications