Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 October 2013
This page provides an overview of the opinions adopted at the October 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.
Three new medicines recommended for approval
This month, the CHMP recommended the approval of Opsumit, an orphan medicine intended for the treatment of pulmonary arterial hypertension in adults.
The Committee gave a positive recommendation for Brintellix in the treatment of major depressive episodes in adults.
The generic medicine Levetiracetam Hospira also received a positive opinion for use in epilepsy.
In the field of epilepsy, the CHMP also recommended switching the marketing authorisation for the orphan medicine Diacomit from a conditional to a full approval. Diacomit is used in children with a very rare type of epilepsy called ‘severe myoclonic epilepsy in infancy’ (SMEI), also known as Dravet’s syndrome. In 2007, the European Commission granted a conditional marketing authorisation for Diacomit on the basis of a CHMP positive opinion. Conditional marketing authorisations are granted for medicines that are likely to have a significant benefit for patients, before all of the formal studies on its efficacy and safety have been completed. As the company has now supplied the additional information necessary, the CHMP has recommended switching from conditional to full approval.
Conditional marketing authorisations are one of the mechanisms put in place by the Agency to facilitate market access for medicines that fulfill unmet medical needs.
Five new extensions of indication
The CHMP recommended granting extensions of indications to Cimzia and Eviplera as well as for three vaccines, Synflorix, Vepacel and Pandemic Influenza Vaccine Baxter H5N1.
Compassionate-use programme for sofosbuvir
The CHMP gave an opinion on the conditions under which early access through compassionate-use programmes could be given for sofosbuvir specifically for patients with chronic hepatitis C virus (HCV) infection before or after liver transplantation. More information is available in a separate press release.
Outcome of safety reviews
The CHMP issued recommendations on the use of intravenous nicardipine.
The Committee has also confirmed its previously recommended changes to the use of metoclopramide-containing medicines as well as to the use of the ergot derivative dihydroergotoxine.
Review of product information underway for Iclusig
Following the emergence of new data on the risk of arterial thrombosis with Iclusig (ponatinib), the Committee concluded that the product information for prescribers and patients should be reviewed and amended if appropriate to include information and warnings on this risk. A formal procedure is currently underway to implement this update.
Election of vice-chair of CHMP
The CHMP has also elected his new vice-chair, Dr Pierre Demolis, for a three-year mandate. Pierre Demolis, a cardiologist by training, is currently Director of the oncology and haematology division at the French Medicines Agency (ANSM). He has been a member of the CHMP since 2007.
More information on these and all other outcomes of this month’s meeting are available in the table below.
Positive recommendations on new medicines
|Name of medicine||Brintellix|
|International non-proprietary name (INN)||vortioxetine|
|Marketing-authorisation applicant||H. Lundbeck A/S|
|Therapeutic indication||Treatment of major depressive episodes|
|More information||Summary of opinion for Brintellix|
|Name of medicine||Opsumit|
|Marketing-authorisation applicant||Actelion Registration Ltd|
|Therapeutic indication||Treatment of pulmonary arterial hypertension (PAH)|
|More information||Summary of opinion for Opsumit|
Positive recommendations on new generic medicine
|Name of medicine||Levetiracetam Hospira|
|Marketing-authorisation applicant||Hospira UK Limited|
|Therapeutic indication||Treatment of seizures|
|More information||Summary of opinion for Levetiracetam Hospira|
Positive recommendations on extensions of therapeutic indications
|Name of medicine||Cimzia|
|Marketing-authorisation holder||UCB Pharma SA|
|More information||Summary of opinion for Cimzia|
|Name of medicine||Eviplera|
|INN||emtricitabine, rilpivirine, tenofovir disoproxil|
|Marketing-authorisation holder||Gilead Sciences International Ltd|
|More information||Summary of opinion for Eviplera|
|Name of medicine||Synflorix|
|INN||pneumococcal polysaccharide conjugate vaccine (adsorbed)|
|Marketing-authorisation holder||GlaxoSmithKline Biologicals|
|More information||Summary of opinion for Synflorix|
|Name of medicine||Vepacel|
|INN||whole virion non-adjuvanted influenza virus, propagated in Vero cells (continuous cell line of mammalian origin)|
|Marketing-authorisation holder||Baxter Innovations GmbH|
|More information||Summary of opinion for Vepacel|
|Name of medicine||Pandemic Influenza Vaccine Baxter H5N1|
|INN||pandemic influenza vaccine (H5N1, whole virion, Vero cell derived, inactivated)|
|Marketing-authorisation holder||Baxter AG|
|More information||Summary of opinion for Pandemic Influenza Vaccine Baxter H5N1|
|Name of medicine||Sofosbuvir|
|Marketing-authorisation holder||Gilead Sciences International Ltd|
|More information||Press release: European Medicines Agency advises on compassionate use of sofosbuvir|
|Name of medicine||Xgeva|
|Marketing-authorisation holder||Amgen Europe B.V.|
|More information||Questions and answers on the outcome of an application for Xgeva to be used in patients with castration-resistant prostate cancer at high risk of spreading to the bones|
Public-health recommendations on non-centrally authorised medicines
|Name of medicine||Intravenous nicardipine|
|More information||Intravenous nicardipine: Article-31 referral|
Re-examinations of public-health recommendations
|Name of medicine||Ergot derivatives|
|More information||Ergot derivatives: Article-31 referral|
|Name of medicine||Metoclopramide-containing medicines|
|More information||Metoclopramide-containing medicines: Article-31 referral|
|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 October 2013 by the Name Review Group (NRG)|
|Opinions on consultation procedures on ancillary medicinal substances in medical devices|
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- Intravenous nicardipine: Article-31 referral
- Ergot derivatives: Article-31 referral
- Metoclopramide-containing medicines: Article-31 referral
- Committee for Medicinal Products for Human Use (CHMP): 21-24 October 2013
- European Medicines Agency gives recommendations on the use of intravenous nicardipine (25/10/2013)
- European Medicines Agency advises on compassionate use of sofosbuvir (25/10/2013)
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.
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