Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2013

This page provides an overview of the opinions adopted at the May 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

Seven new medicines recommended for approval

The CHMP recommended the approval of Pomalidomide Celgene for the treatment of multiple myeloma. A separate press release on this medicine is included in the table below.

A new vaccine against smallpox, Imvanex, was recommended for approval for use in the European Union under exceptional circumstances.

The Committee also recommended the granting of a marketing authorisation for Lonquex, a medicine for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy.

The CHMP also gave a positive recommendation for the approval of Voncento for the prevention and treatment of bleeding in von Willebrand disease and haemophilia A (congenital FVIII deficiency).

Lojuxta received a positive opinion from the CHMP for the treatment of homozygous familial hypercholesterolaemia, in addition to a low fat diet and other lipid-lowering medicinal products.

A new medicine, Somatropin Biopartners, was granted marketing authorisation by the CHMP as a replacement therapy for endogenous growth hormone deficiency.

The CHMP also recommended that the generic medicine Atosiban Sun should be granted marketing authorisation for the delay of imminent pre-term birth in pregnant adult women.

Four recommendations for extension of indication

The CHMP recommended an extension of the existing indications for Glivec, Lucentis, Prevenar 13 and Tysabri. An application to extend another indication for Tysabri has been withdrawn.

Withdrawal

A question-and-answer document on the withdrawal of marketing authorisation application for Belviq (lorcaserin) is also published below.

More information on these and all other outcomes of the CHMP May 2013 meeting is available in the table below.

Positive recommendations on new medicines

Name of medicine	Imvanex
Common name	modified Vaccinia Ankara virus
Marketing-authorisation applicant	Bavarian Nordic A/S
Therapeutic indication	Active immunisation against smallpox infection.
More information	CHMP summary of positive opinion for Imvanex

Name of medicine	Lojuxta
Common name	lomitapide
Marketing-authorisation applicant	Aegerion Pharmaceuticals
Therapeutic indication	Adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low-density-lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH).
More information	CHMP summary of positive opinion for Lojuxta

Name of medicine	Lonquex
International non-proprietary name (INN)	lipegfilgrastim
Marketing-authorisation applicant	Teva Pharma B.V.
Therapeutic indication	Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
More information	CHMP summary of positive opinion for Lonquex

Name of medicine	Pomalidomide Celgene
INN	pomalidomide
Marketing-authorisation applicant	Celgene Europe Ltd
Therapeutic indication	Treatment of multiple myeloma.
More information	CHMP summary of positive opinion for Pomalidomide Celgene Press release: European Medicines Agency recommends approval of pomalidomide for the treatment of multiple myeloma

Name of medicine	Somatropin Biopartners
INN	somatropin
Marketing-authorisation applicant	BioPartners GmbH
Therapeutic indication	Replacement therapy of endogeous growth hormone.
More information	CHMP summary of positive opinion for Somatropin Biopartners

Name of medicine	Voncento
INN	human coagulation factor VIII / human Von Willebrand factor
Marketing-authorisation applicant	CLS Behring GmbH
Therapeutic indication	Treatment and prevention of bleedings in Von Willebrand disease (VWD) and haemophilia A (congenital factor-VIII deficiency).
More information	CHMP summary of positive opinion for Voncento

Positive recommendation on a new generic medicine

Name of medicine	Atosiban Sun
INN	atosiban
Marketing-authorisation applicant	Sun Pharmaceutical Industries Europe B.V.
Therapeutic indication	To delay imminent pre-term birth in pregnant adult women.
More information	CHMP summary of positive opinion for Atosiban SUN

Positive recommendations on extensions of therapeutic indications

Name of medicine	Glivec
INN	imatinib
Marketing-authorisation holder	Novartis Europharm Ltd
New indication	Treatment of paediatric patients with newly diagnosed Philadelphia-chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
More information	CHMP post-authorisation summary of positive opinion for Glivec

Name of medicine	Lucentis
INN	ranibizumab
Marketing-authorisation holder	Novartis Europharm Ltd
New indication	Treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM).
More information	CHMP post-authorisation summary of positive opinion for Lucentis

Name of medicine	Prevenar 13
Common name	pneumococcal polysaccharide conjugate vaccine
Marketing-authorisation holder	Pfizer Ltd
Change to a therapeutic indication (changes in bold)	Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from six weeks to 17 years of age. Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults ?18 years of age and the elderly. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.
More information	CHMP post-authorisation summary of positive opinion for Prevenar 13

Name of medicine	Tysabri
INN	natalizumab
Marketing-authorisation holder	Elan Pharma International Ltd
New indication	Adult patients aged 18 years and over with high disease activity despite treatment with glatiramer acetate.
More information	CHMP post-authorisation summary of positive opinion for Tysabri

Final opinion on restriction of therapeutic indication

Name of medicine	Trobalt
INN	retigabine
Marketing-authorisation holder	Glaxo Group Ltd
More information	European Medicines Agency recommends restricting Trobalt to last-line therapy in partial epilepsy

Other opinions

Name of medicine	Lantus, Optisulin
INN	insulin glargine
Marketing-authorisation holder	sanofi-aventis Deutschland GmbH
More information	Outcome of review of new safety data on insulin glargine

Name of medicine	Lysodren
Common name	mitotane
Marketing-authorisation holder	Laboratoire HRA Pharma
More information	Questions and answers on the outcome of an extension of indication application for Lysodren (mitotane)