Dunn, Allison, Jung, Dawoon, Bollinger, Lisa, Krams, Michael, Smith, Brian and Gobburu, Jogarao (2022) Accelerating Availability of Medicines to Pediatrics via Extrapolation of Efficacy from Adults. Therapeutic Innovation & Regulatory Science, 56 (6). pp. 873-882. ISSN 2168-4790

Abstract

Improving pediatric therapeutic development is a mission of universal importance amongst health authorities, pharmaceutical companies, academic institutions, and healthcare professionals. Following the passage of legislation in the United States and Europe, we witnessed the most significant advancement yet in pediatric data generation, resulting in added pediatric use information to almost 700 product labels. Tools to accelerate generation of data for the pediatric population are available for use today, and when utilized in accordance with current practices and laws, these tools could increase the amount and timeliness of pediatric information available for clinicians and patients. If we utilize the current laws that allow regulators to incentivize and require evidence generation, apply extrapolation and utilize modeling and simulation, as well as including adolescents in the pivotal studies alongside adults as appropriate, two strategic goals could be achieved by 2030: 1) reduce the time to pediatric approval by 50%, and 2) renew pediatric labeling information for 15 priority pediatric drugs without patent and/or exclusivity.

Item Type:	Article
Date Deposited:	23 Nov 2022 00:45
Last Modified:	23 Nov 2022 00:46
URI:	https://oak.novartis.com/id/eprint/46515