Cargando…
Cardiovascular Paediatric Medicines Development: Have Paediatric Investigation Plans Lost Heart?
This work aimed to establish whether paediatric needs in cardiovascular diseases have been met by paediatric investigation plans (PIPs) produced since the development of the European Union Paediatric Regulation in 2007. The European Medicines Agency repository was searched for patterns in the develo...
Autores principales: | , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7761547/ https://www.ncbi.nlm.nih.gov/pubmed/33276598 http://dx.doi.org/10.3390/pharmaceutics12121176 |
_version_ | 1783627594195795968 |
---|---|
author | Faulkner, Bethany Delgado-Charro, M. Begoña |
author_facet | Faulkner, Bethany Delgado-Charro, M. Begoña |
author_sort | Faulkner, Bethany |
collection | PubMed |
description | This work aimed to establish whether paediatric needs in cardiovascular diseases have been met by paediatric investigation plans (PIPs) produced since the development of the European Union Paediatric Regulation in 2007. The European Medicines Agency repository was searched for patterns in the development of paediatric medicines in general. Next, positive PIPs related to cardiovascular diseases were scrutinized for outcomes and compared to specific paediatric cardiovascular needs. In total, 1866 PIPs were identified with 12% corresponding to decisions taken for cardiovascular medicines. However, despite this therapeutic area having the greatest number of overall PIPs, only 14% of established needs in paediatric cardiovascular diseases were addressed by PIPs with positive decisions. Further, 71.9% of PIPs with decisions in cardiovascular disease corresponded to full waivers, so the product would not be studied in paediatrics. Despite the progress found in overall numbers of PIPs published, cardiovascular products are still commonly used off-label in paediatrics. Particularly, there is a need to develop products to treat heart failure and hypertension, two areas with clear unmet clinical needs in paediatrics. A case study on valsartan showed that industry, regulators, health technology assessment bodies, and prescribers should work together to reduce off-label use of paediatric cardiovascular diseases (CVD). |
format | Online Article Text |
id | pubmed-7761547 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-77615472020-12-26 Cardiovascular Paediatric Medicines Development: Have Paediatric Investigation Plans Lost Heart? Faulkner, Bethany Delgado-Charro, M. Begoña Pharmaceutics Article This work aimed to establish whether paediatric needs in cardiovascular diseases have been met by paediatric investigation plans (PIPs) produced since the development of the European Union Paediatric Regulation in 2007. The European Medicines Agency repository was searched for patterns in the development of paediatric medicines in general. Next, positive PIPs related to cardiovascular diseases were scrutinized for outcomes and compared to specific paediatric cardiovascular needs. In total, 1866 PIPs were identified with 12% corresponding to decisions taken for cardiovascular medicines. However, despite this therapeutic area having the greatest number of overall PIPs, only 14% of established needs in paediatric cardiovascular diseases were addressed by PIPs with positive decisions. Further, 71.9% of PIPs with decisions in cardiovascular disease corresponded to full waivers, so the product would not be studied in paediatrics. Despite the progress found in overall numbers of PIPs published, cardiovascular products are still commonly used off-label in paediatrics. Particularly, there is a need to develop products to treat heart failure and hypertension, two areas with clear unmet clinical needs in paediatrics. A case study on valsartan showed that industry, regulators, health technology assessment bodies, and prescribers should work together to reduce off-label use of paediatric cardiovascular diseases (CVD). MDPI 2020-12-02 /pmc/articles/PMC7761547/ /pubmed/33276598 http://dx.doi.org/10.3390/pharmaceutics12121176 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Faulkner, Bethany Delgado-Charro, M. Begoña Cardiovascular Paediatric Medicines Development: Have Paediatric Investigation Plans Lost Heart? |
title | Cardiovascular Paediatric Medicines Development: Have Paediatric Investigation Plans Lost Heart? |
title_full | Cardiovascular Paediatric Medicines Development: Have Paediatric Investigation Plans Lost Heart? |
title_fullStr | Cardiovascular Paediatric Medicines Development: Have Paediatric Investigation Plans Lost Heart? |
title_full_unstemmed | Cardiovascular Paediatric Medicines Development: Have Paediatric Investigation Plans Lost Heart? |
title_short | Cardiovascular Paediatric Medicines Development: Have Paediatric Investigation Plans Lost Heart? |
title_sort | cardiovascular paediatric medicines development: have paediatric investigation plans lost heart? |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7761547/ https://www.ncbi.nlm.nih.gov/pubmed/33276598 http://dx.doi.org/10.3390/pharmaceutics12121176 |
work_keys_str_mv | AT faulknerbethany cardiovascularpaediatricmedicinesdevelopmenthavepaediatricinvestigationplanslostheart AT delgadocharrombegona cardiovascularpaediatricmedicinesdevelopmenthavepaediatricinvestigationplanslostheart |