Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 October 2013

News 25/10/2013

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 medicineBrintellix
International non-proprietary name (INN)vortioxetine
Marketing-authorisation applicantH. Lundbeck A/S
Therapeutic indicationTreatment of major depressive episodes
More information PDF iconSummary of opinion for Brintellix

Name of medicineOpsumit
INNmacitentan
Marketing-authorisation applicantActelion Registration Ltd
Therapeutic indicationTreatment of pulmonary arterial hypertension (PAH)
More information PDF iconSummary of opinion for Opsumit

Positive recommendations on new generic medicine

Name of medicineLevetiracetam Hospira
INNlevetiracetam
Marketing-authorisation applicantHospira UK Limited
Therapeutic indicationTreatment of seizures
More information PDF iconSummary of opinion for Levetiracetam Hospira

Positive recommendations on extensions of therapeutic indications

Name of medicineCimzia
INNcertolizumab pegol
Marketing-authorisation holderUCB Pharma SA
More information PDF iconSummary of opinion for Cimzia

Name of medicineEviplera
INNemtricitabine, rilpivirine, tenofovir disoproxil
Marketing-authorisation holderGilead Sciences International Ltd
More information PDF iconSummary of opinion for Eviplera

Name of medicineSynflorix
INNpneumococcal polysaccharide conjugate vaccine (adsorbed)
Marketing-authorisation holderGlaxoSmithKline Biologicals
More information PDF iconSummary of opinion for Synflorix

Name of medicineVepacel
INNwhole virion non-adjuvanted influenza virus, propagated in Vero cells (continuous cell line of mammalian origin)
Marketing-authorisation holderBaxter Innovations GmbH
More information PDF iconSummary of opinion for Vepacel

Name of medicinePandemic Influenza Vaccine Baxter H5N1
INNpandemic influenza vaccine (H5N1, whole virion, Vero cell derived, inactivated)
Marketing-authorisation holderBaxter AG
More information PDF iconSummary of opinion for Pandemic Influenza Vaccine Baxter H5N1

Compassionate use

Name of medicineSofosbuvir
INNsofosbuvir
Marketing-authorisation holderGilead Sciences International Ltd
More informationPress release: European Medicines Agency advises on compassionate use of sofosbuvir

Other opinions

Name of medicineXgeva
INNdenosumab
Marketing-authorisation holderAmgen Europe B.V.
More information PDF iconQuestions 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 medicineIntravenous nicardipine
INNnicardipine
More informationIntravenous nicardipine: Article-31 referral

Re-examinations of public-health recommendations

Name of medicineErgot derivatives
INNdihydroergotoxine
More informationErgot derivatives: Article-31 referral

Name of medicineMetoclopramide-containing medicines
INNmetoclopramide
More informationMetoclopramide-containing medicines: Article-31 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
PDF iconOverview of invented names reviewed in October 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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