Three new medicines have been recommended for approval by the Committee for Medical Products for Human Use (CHMP) in the past month.
The first recommended was Opsumit, an orphan medicine intended for the treatment of pulmonary arterial hypertension in adults. Following this the committee gave a positive recommendation for Brintellix in the treatment of major depressive episodes in adults. Finally, the generic medicine Levetiracetam Hospira also received a positive opinion for use in epilepsy.
Regarding 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.