EMA grants first paediatric use marketing authorisation
pharmafile | September 9, 2011 | News story | Sales and Marketing | Buccolam, PUMA, Viropharma, paediatric trials, seizures
The first children’s medicine to hold a new paediatric use marketing authorisation (PUMA), making it available for children only, has been granted approval by European regulators.
ViroPharma’s Buccolam (midazolam, oromucosal solution) has been specifically licensed for infants, toddlers, children and adolescents to treat severe convulsions and epileptic seizures.
“This is excellent news for children in Europe who suffer from these serious convulsions,” said Dr June Raine, director of vigilance and risk management of medicines at UK regulator the MHRA.
The idea is to provide the correct dose in the right form for the child. “They are not simply ‘small adults’ and they respond differently to medication,” continued Raine. “Children should have access to medicines that have been especially designed for them.”
Indicated for use in patients aged three months to 18 years of age, Buccolam received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June and will now be available across all EU states as well as Norway, Iceland and Liechtenstein.
It comes in a pre-filled syringe at an age-specific dose and is administered via the cavity between the cheek and gum. This is a major advantage over the current treatment option, which is rectally-administered diazepam.
When it comes to terminating pediatric convulsive seizures, Buccolam has also been shown as either comparable to, or better than, diazepam in four clinical studies.
“We look forward to working closely with physicians across Europe as we launch Buccolam into the European markets,” said Thierry Darcis, ViroPharma’s vice president, general manager, Europe.
MHRA says it hopes the drug will be the first of many such ‘children’s only’ treatments to be made available in the UK.
The European Commission’s PUMA procedure was introduced to cover medicines which are exclusively developed for use in children and have already been authorised, but which are no longer covered by intellectual property rights. Such medicines are granted ten years of market protection.
Many seizures affecting pediatric patients are the result of epilepsy, but they can also be triggered by medicines, head injuries, some diseases and high fevers causing febrile seizures – the most common kind in children.
Adam Hill
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