Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2013
News
Human
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 An application to extend another indication for Tysabri has been withdrawn.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) |
Withdrawal of applications
| Name of medicine | Belviq |
|---|---|
| INN | lorcaserin hydrochloride |
| More information | Belviq: Withdrawn application |
| Name of medicine | Tysabri |
|---|---|
| INN | natalizumab |
| More information | Tysabri: Withdrawn application |
Outcome of arbitration procedure
| Name of medicine | Targocid |
|---|---|
| INN | teicoplanin |
| Marketing-authorisation holder | Sanofi-Aventis Group |
| More information | Targocid and associated names: Article-30 referral |
Other updates
| Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting 27-30 May 2013 |
| Opinions on safety variations adopted at the CHMP meeting 27-30 May 2013 |
| Start of Community reviews - CHMP meeting of 27-30 May 2013 |
| Scientific advice and protocol assistance adopted during the CHMP meeting of 27-30 May 2013 |
| Guidelines and concept papers adopted during the CHMP meeting 27-30 May 2013 |
| Overview of invented names reviewed in April 2013 by the Name Review Group (NRG) |
| Organisational matters - CHMP meeting 27-30 May 2013 |
| Opinions on consultation procedures on ancillary medicinal substances in medical devices |