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Labeling of Enalapril from Neonates up to Adolescents

Objective

Children are often treated as small adults—not as the special patients they are. Regulations exist to encourage the development of drugs and formulation for children. However, off-patent drugs are often administered to children without appropriate formulations or systematic investigations. Therefore, the paediatric use marketing authorisation (PUMA) has been designed.
The EMA Paediatric Working Party has prioritized the unmet need for the cardiovascular off-patent drug enalapril in the European paediatric population. Enalapril is an ACE inhibitor commonly used for cardiac failure in children under 1 year of age, although it is not labelled for any condition in patients <20 kg in European countries.
Current problems with the use of enalapril in children include: no appropriate formulation and insufficient stability of the liquid soluble formulation for young paediatric patients; insufficient paediatric pharmacokinetic (PK) data for any formulation; insufficient safety data in neonates, infants, and young children; and limited pharmacodynamics (PD) and efficacy data for paediatric cardiological indications.
The aim of the LENA (Labeling of Enalapril from Neonates up to Adolescents) project is to address these shortcomings and provide a basis for a future PUMA of enalapril by developing an age-appropriate solid oral formulation suitable for all paediatric subsets; generating PK and PD data; collecting data on the safety of enalapril in young paediatric patients; and providing dose recommendations based on PK/PD modelling and bridging from adult data.
The international collaboration of the LENA investigators will provide the required expertise to develop and evaluate drug formulation, investigate dosing, and recruit paediatric patients for clinical trials while respecting current legislation, regulatory considerations, and ethical aspects, with the aim of applying for a PUMA.

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

HEINRICH-HEINE-UNIVERSITAET DUESSELDORF
Address
Universitaetsstrasse 1
40225 Dusseldorf
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 2 175 012
Administrative Contact
Martina Kuhlmann (Ms.)

Participants (13)

ETHICARE GMBH
Germany
EU contribution
€ 774 719
Address
Am Fliederbusch 2
45721 Haltern Am See
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Wolfgang Wiedey (Dr.)
PHARMAPLEX BVBA
Belgium
EU contribution
€ 430 500
Address
Sint Hubertuslaan 51
1970 Wezembeek Oppem
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ingrid Klingmann (Dr.)
GOTTSEGEN GYORGY ORSZAGOS KARDIOLOGIAI INTEZET
Hungary
EU contribution
€ 48 656
Address
Haller Utca 29
1096 Budapest
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Andras Szatmari (Prof.)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 603 207
Address
Dr Molewaterplein 40
3015 GD Rotterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ellen Schenk (Ms.)
UNIVERZITETSKA DECJA KLINIKA
Serbia
EU contribution
€ 374 808
Address
Ul Tirsova 10
11000 Beograd
Activity type
Research Organisations
Administrative Contact
Milica Bajcetic (Prof.)
PARACELSUS MEDIZINISCHE PRIVATUNIVERSITAT SALZBURG - PRIVATSTIFTUNG
Austria
EU contribution
€ 336 900
Address
Strubergasse 21
5020 Salzburg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Michael Nake (Dr.)
Childrens Heart Federation
United Kingdom
EU contribution
€ 231 800
Address
Great Eastern Street 2-4
EC2A 3NW London
Activity type
Other
Administrative Contact
Anne Keatley-Clarke (Ms.)
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Participation ended

Germany
EU contribution
€ 135 234
Address
Oskar Von Miller Ring 29
80333 Muenchen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Birgit Fuchs (Mrs.)
GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 266 484
Address
Great Ormond Street
WC1N 3JH London
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Claire Newton (Mrs.)
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 240 240
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Elke Lammertyn (Dr.)
MEDIZINISCHE UNIVERSITAET WIEN
Austria
EU contribution
€ 117 753
Address
Spitalgasse 23
1090 Wien
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ina Michel-Behnke (Prof.)
UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands
EU contribution
€ 70 214
Address
Heidelberglaan 100
3584 CX Utrecht
Activity type
Higher or Secondary Education Establishments
Administrative Contact
D.M. Looy (Ms.)
ARTTIC
France
EU contribution
€ 194 464
Address
Rue Du Dessous Des Berges 58A
75013 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Martin Dietz (Dr.)