Download Interactions between CHMP and PDCO

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
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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)
Relax – I will not try to be the judge
CHMP – PDCO interactions
• PDCO-members (bridge to CHMP)
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
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
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)
CHMP – PDCO interactions
• PDCO-members (bridge to CHMP)
• SAWP
• Some examples (MAAs)
Examples
• Enbrel; RoActemra (extrapolation of
efficacy)
– Enbrel: to extend the lower age range in
polyarticular juvenile idiopathic arthritis (JIA)
from four to two years.
Examples
• Enbrel/RoActemra (extrapolation of
efficacy)
• Buccolam (PUMA)
European Medicines Agency gives first positive opinion for
paediatric-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
In summary…
• Lots of PIPs
• Many SA related to paediatrics
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)
The future…… (?)
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PRAC
CAT
CHMP
PDCO
- PASS
– conditional approvals
– PAES, HTA
– PIP
The future…… (?)
•
•
•
•
PRAC
CAT
CHMP
PDCO
- PASS
- conditional approvals
– PAES, HTA
– PIP
We (CHMP) need a system to initially provide an
outline of a follow-up measure and later a more
detailed advice (through SAWP). This may be a
model that can be explored for other committees