Use of real-world data for new drug applications and line extensions.

Use of real-world data for new drug applications and line extensions.
Clin Ther. 2020 Apr 24;:
Authors: Bolislis WR, Fay M, Kühler TC
Abstract
PURPOSE: For this article, the authors compiled, summarized, and analyzed data from 27 cases in which real-world data (RWD) were applied in regulatory approval. The aims were to provide an overview of RWD, based on classifications per therapeutic area, age group, drivers of acceptability, utility, data sources, and timelines, and to present insights on how it has been applied in regulatory decision making to date.
METHODS: Clarivate Analytics was commissioned to collect data from cases in which RWD was used for new drug applications and line extensions submitted to the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), Health Canada, and Japan's Pharmaceuticals and Medical Devices Agency. The query resulted in 27 cases in which regulatory approval was associated with RWD. The data were then categorized and elaborated with supporting information gathered from public databases and company websites.
FINDINGS: There were 17 identified cases in which RWD were used for new drug applications, and 10 for line extensions, between the years 1998 and 2019. Approvals were spread across regulatory bodies: the EMA alone (6 cases), the FDA alone (4 cases), or jointly between the EMA and FDA or other regulatory bodies. The applications were also distributed across age...

Source: Clinical Therapeutics - April 23, 2020 Category: Drugs & Pharmacology Authors: Bolislis WR, Fay M, Kühler TC Tags: Clin Ther Source Type: research