EMA gives first positive opinion for a Paediatric use Marketing Authorisation (PUMA)

15 July 2011

Mary Smillie

Regulation (EC) No. 1901/2006 (the Paediatric Regulation) sets out the incentives for applicants complying with the paediatric investigation plan (PIP) which is intended to provide health care professionals and patients with information on the safe and effective use of medicines in the paediatric population. 

The incentive for authorised products no longer covered by patents and supplementary certificates is a new type of marketing authorisation, called the Paediatric use Marketing Authorisation or PUMA.  Although the provisions in the Paediatric Regulation covering the PUMA (Articles 30 and 31) came into force on 26 July 2007, the first positive opinion for a PUMA was given by the CHMP in June 2011.

The PUMA is for a product with the brand-name Buccolam® which contains the active ingredient midazolam.  The applicant ViroPharma SPRL has developed a paediatric formulation for prolonged, acute, convulsive seizures in children aged from 3 months to 18 years.  In return for undertaking the clinical studies in children ViroPharma will obtain “8 + 2 + 1” years’ data exclusivity once the Marketing Authorisation is granted. 

Midazolam is also the active ingredient in the Roche product Hypnovel® which has been authorised in the UK since 1984 and is used for sedation e.g. as a pre-medication before anaesthesia. 

The positive opinion for Buccolam® has taken under two years from the approval of the PIP by the Paediatric Committee (PDCO) on 11 August 2009.  The Marketing Authorisation application was submitted on 22 September 2010 and had an active review time of 210 days.  The positive opinion of the CHMP was given at its meeting on 20-23 June 2011. 

The EMA states that another 25 applications for PIPs for PUMAs have been received and seven opinions have been given by the PDCO.