Senior Directors from Aetion (Purpura and Harvey) analyzed four approvals for products intended to treat or prevent infectious diseases from 2019 that included RWE studies to highlight how foreign postmarketing data improves understanding of a product’s risk-benefit profile. The products examined included: DENGVAXIA® (Dengue Tetravalent Vaccine, Live), EGATEN™ (triclabendazole), JYNNEOS® (Smallpox and Monkeypox Vaccine, Live, Non-Replicating), and RECARBRIO™ (imipenem, cilastatin, and relebactam).
The authors conclude that these four cases demonstrate how RWE is used for label expansion and post-approval safety reporting, and underscore how real world data, when fit for purpose, has been used to generate evidence to support product approval. FDA Commissioner Stephen Hahn, M.D., stated, “The more experience we have with real-world evidence, the more confidence we will have in using it for product decisions.”
(Source: Purpua C, Harvey R. Aetion, July 30, 2020)