interactions between chmp and pdco; reflections from a chmp perspective tomas salmonson vice-chair,...
TRANSCRIPT
Interactions between CHMP and PDCO; reflections from a CHMP perspective
Tomas Salmonson
vice-chair, CHMP
5 years of the Paediatric regulation whose objectives are:
– to increase the availability of medicines intended for children
– to make information on those medicines widely available
– to stimulate high quality paediatric research.
Early concerns from CHMP
• Delay in drug development
• Timing of studies in children
• PIP vs SA
• Too "heavy" procedure (for industry and regulators)
Early concerns from CHMP
• Delay in drug development
• Timing of studies in children
• PIP vs SA
• Too "heavy" procedure (for industry and regulators)
CHMP – PDCO interactions
• PDCO-members (bridge to CHMP)– has not worked - I still believe my proposal
would have been a better one
CHMP – PDCO interactions
• PDCO-members (bridge to CHMP)
• SAWP– 250 PIPs received EMA scientific advice or protocol
assistance before or after PIP opinion– PDCO members / EMA paed staff have been
involved in 205 SAWP procedures – PDCO delegates are automatically involved in paediatric SA/PA
– an empty "PDCO-chair " at SAWP– SAWP not consulted in PIP-discussions
CHMP – PDCO interactions
• PDCO-members (bridge to CHMP)
• SAWP
• Guidelines– PDCO involvement in guidelines drafting
(e.g.: adopted this year Paediatric addendum for PAH, Clinical investigation of recombinant and human plasma-derived factor VIII products and factor IX)
Examples
• Enbrel; RoActemra (extrapolation of efficacy)– Enbrel: to extend the lower age range in
polyarticular juvenile idiopathic arthritis (JIA) from four to two years.
European Medicines Agency gives first positive opinion forpaediatric-use marketing authorisation
Buccolam recommended for treatment of prolonged, acute, convulsive seizures in paediatric patients from 3 months to 18 years
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given its first positive opinion for a paediatric-use marketing authorisation (PUMA) for Buccolam(midazolam), from ViroPharma SPRL, intended for the treatment of prolonged, acute, convulsive seizures in paediatric patients from the age of 3 months to 18 years.
June 2011 (PIP approved August 2009)
Dr Agnès Saint-Raymond said:
“We welcome this first opinion for a PUMA. Since the coming into force of the Paediatric Regulation in 2007 companies have given too little attention to the incentives for paediatric-use marketing authorisations.”
Examples
• Enbrel/RoActemra (extrapolation of efficacy)
• Buccolam (PUMA)
• Schizofrenia (joint SAG, Invega)
In summary…
• Lots of PIPs
• Many SA related to paediatrics
• Significant interactions between SAWP and PDCO (still room for improvement)
In summary…
• Lots of PIPs
• Many SA related to paediatrics
• Significant interactions between SAWP and PDCO (still room for improvement)
• Few direct interactions between PDCO and CHMP (big room for improvement)
In summary…
• Lots of PIPs
• Many SA related to paediatrics
• Significant interactions between SAWP and PDCO (still room for improvement)
• Few direct interactions between PDCO and CHMP (big room for improvement)
• Few applications – too early to judge??– eg: 26 applications for PIPs for PUMAs have been received
and 7 opinions have been given by the PDCO. (June 2011)