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 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
INN	macitentan
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
INN	levetiracetam
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
INN	certolizumab pegol
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

Compassionate use

Name of medicine	Sofosbuvir
INN	sofosbuvir
Marketing-authorisation holder	Gilead Sciences International Ltd
More information	Press release: European Medicines Agency advises on compassionate use of sofosbuvir

Other opinions

Name of medicine	Xgeva
INN	denosumab
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