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.

 

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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.

 

Posted on the EMA website on 25 October 2013