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

News 31/05/2013

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 An application to extend another indication for Tysabri has been withdrawn.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 medicineImvanex
Common namemodified Vaccinia Ankara virus
Marketing-authorisation applicantBavarian Nordic A/S
Therapeutic indicationActive immunisation against smallpox infection.
More information PDF iconSummary of opinion for Imvanex

Name of medicineLojuxta
Common namelomitapide
Marketing-authorisation applicantAegerion Pharmaceuticals
Therapeutic indicationAdjunct 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 PDF iconSummary of opinion for Lojuxta

Name of medicineLonquex
International non-proprietary name (INN)lipegfilgrastim
Marketing-authorisation applicantTeva Pharma B.V.
Therapeutic indicationReduction 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 informationSummary of opinion for Lonquex

Name of medicinePomalidomide Celgene
INNpomalidomide
Marketing-authorisation applicantCelgene Europe Ltd
Therapeutic indicationTreatment of multiple myeloma.
More information

PDF iconSummary of opinion for Pomalidomide Celgene

Press release: European Medicines Agency recommends approval of pomalidomide for the treatment of multiple myeloma

Name of medicineSomatropin Biopartners
INNsomatropin
Marketing-authorisation applicantBioPartners GmbH
Therapeutic indicationReplacement therapy of endogeous growth hormone.
More informationSummary of opinion for Somatropin Biopartners

Name of medicineVoncento
INNhuman coagulation factor VIII / human Von Willebrand factor
Marketing-authorisation applicantCLS Behring GmbH
Therapeutic indicationTreatment and prevention of bleedings in Von Willebrand disease (VWD) and haemophilia A (congenital factor-VIII deficiency).
More information PDF iconSummary of opinion for Voncento

Positive recommendation on a new generic medicine

Name of medicineAtosiban Sun
INNatosiban
Marketing-authorisation applicantSun Pharmaceutical Industries Europe B.V.
Therapeutic indicationTo delay imminent pre-term birth in pregnant adult women.
More information PDF iconSummary of opinion for Atosiban Sun



Positive recommendations on extensions of therapeutic indications

Name of medicineGlivec
INNimatinib
Marketing-authorisation holderNovartis Europharm Ltd
New indicationTreatment of paediatric patients with newly diagnosed Philadelphia-chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
More information PDF iconSummary of opinion for Glivec

Name of medicineLucentis
INNranibizumab
Marketing-authorisation holderNovartis Europharm Ltd
New indicationTreatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM).
More information PDF iconSummary of opinion for Lucentis

Name of medicinePrevenar 13
Common namepneumococcal polysaccharide conjugate vaccine
Marketing-authorisation holderPfizer 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 PDF iconSummary of opinon for Prevenar 13

Name of medicineTysabri
INNnatalizumab
Marketing-authorisation holderElan Pharma International Ltd
New indicationAdult patients aged 18 years and over with high disease activity despite treatment with glatiramer acetate.
More information PDF iconSummary of opinion for Tysabri



Final opinion on restriction of therapeutic indication

Name of medicineTrobalt
INNretigabine
Marketing-authorisation holderGlaxo Group Ltd
More informationEuropean Medicines Agency recommends restricting Trobalt to last-line therapy in partial epilepsy

Other opinions

Name of medicineLantus, Optisulin
INNinsulin glargine
Marketing-authorisation holdersanofi-aventis Deutschland GmbH
More information PDF iconOutcome of review of new safety data on insulin glargine

Name of medicineLysodren
Common namemitotane
Marketing-authorisation holderLaboratoire HRA Pharma
More information PDF iconQuestions and answers on the outcome of an extension of indication application for Lysodren

Withdrawal of applications

Name of medicineBelviq
INNlorcaserin hydrochloride
More informationBelviq: Withdrawn application

Name of medicineTysabri
INNnatalizumab
More informationTysabri: Withdrawn application


Outcome of arbitration procedure

Name of medicineTargocid
INNteicoplanin
Marketing-authorisation holderSanofi-Aventis Group
More informationTargocid and associated names: Article-30 referral


Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
PDF iconStart of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
Overview of invented names reviewed in April 2013 by the Name Review Group (NRG)
PDF iconOrganisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

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