Novartis Vaccines and Diagnostics S.r.l. has formally notified the EMA of its intention to withdraw the paediatric-use marketing authorisation (PUMA) for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted with MF59C.1).

The EMA was informed in an official letter that Novartis were unable to address the questions raised by the Committee for Medicinal Products for Human Use (CHMP) within the required timelines.

The European healthcare regulator said the withdrawal does not prejudice the possibility of Novartis making a new application at a later stage.

Fluad Paediatric was intended to be used for the active immunisation against influenza in infants and young children. Its initial application was submitted to the EMA in December 2010. At the time of the withdrawal, it was under evaluation by the CHMP.

ViroPharma’s Buccolam has been specifically licensed for infants, children and adolescents to treat severe convulsions and epileptic seizures in Europe.

It is the first children’s medicine to be granted the Paediatric Use Marketing Authorisation (PUMA), delivering an age-specific dose in the right form for the child.

Dr June Raine, Director of Vigilance and Risk Management of Medicines, MHRA, said: “They are not simply ‘small adults’ and they respond differently to medication”.

The midazolam and oromucosal solution comes in a pre-filled syringe indicated for patients aged three months to 18 years of age.

The dose is administered via the cavity between the cheek and gum, a less invasive method than its current treatment option, which is rectally-administered diazepam.

The marketing authorisation is based on data gathered from four clinical trials testing Buccolam against diazepam, where Buccolam proved to be either comparable to, or better than the existing treatment.

“Children should have access to medicines that have been especially designed for them,” added Dr Raine.

The medicine previously received a positive opinion in June from the Committee for the Medicinal Products for Human Use (CHMP) and will now be available across the EU as well as Norway, Iceland and Liechtenstein.

Thierry Darcis, Vice President and General Manager of ViroPharma Europe, said: “We look forward to working closely with physicians across Europe as we launch Buccolam into the European markets”.

ViroPharma’s Buccolam (midazolam, oromucosal solution) has been given a positive opinion by the CHMP for the treatment of seizures in patients aged three months up to 18 years old.

The treatment, if approved by the European Commission, would become the first product approved through the centralised ‘Pediatric Use Marketing Authorization’ (PUMA) procedure.

Professor Ian Wong, Director of the Centre for Paediatric Pharmacy Research at the School of Pharmacy, University of London, says the treatment “would be an important, convenient and welcomed alternative to treat seizures”.

The oral midazolam has been shown in four clinical studies to be either comparable or superior in both its effectiveness and speed of onset of action to the current standard treatment.

Thierry Darcis, ViroPharma’s Vice President and General Manager in Europe, says the positive opinion is a “great step” for a product that “addresses significant unmet need for families and caregivers”.

He added that the company is working closely with healthcare professionals across Europe to bring this “much-needed emergency medication” to market as soon as possible.

PUMA is a new type of marketing authorisation for products that are developed specifically for children. These medicines benefit from 10 years of market protection.