The first ever children’s medicine to hold a new paediatric use marketing authorisation (PUMA) has been granted by the European Commission.
The medicine, Buccolam, is now specifically licensed for children aged three months to 18 years to treat severe convulsions and epileptic seizures.
The authorisation represents a landmark for efforts to improve the quality, safety and efficacy of children’s medicines available in the UK.
The Medicines and Healthcare products Regulatory Agency has been advocating the increased availability of “specific children’s only medicines for several years in recognition that many adult medicines are offered to children in cut-down doses”.
Dr June Raine, MHRA director of vigilance and risk management of medicines, said: “This is excellent news for children in Europe who suffer from these serious convulsions.
“Children’s only medicines are of great benefit as they provide the right dose in the right form for kids.
“They are not simply ‘small adults’ and they respond differently to medication. Children should have access to medicines that have been especially designed for them.
“We hope today’s announcement and the introduction of the first PUMA will lead to many more children’s only medicines being made available in the UK.”
The European Commission granted the first PUMA for the medicine Buccolam (midazolam for buccal administration), manufactured by ViroPharma SPRL.
It is intended for the treatment of prolonged, acute, convulsive seizures in paediatric patients from the age of three months to 18 years. It is expected that the product will be available in the UK from early October 2011.
The European Medicines Agency’s Committee for Medicinal Products for Human Use gave the drug a positive opinion on 23 June, paving the way for the authorisation.
The PUMA is a new type of licence introduced by the European Paediatric Regulation, which is designed to encourage the development of older medicines no longer covered by a patent specifically for use in children.
It is supported by an agreed paediatric investigation plan and when granted, it gives the product the same data and market exclusivity as a completely new medicine. PUMAs may be granted by national licensing authorities or, as in this case, by the European Commission for a Europe-wide authorisation.