Aetion’s FDA Decision Alert Library includes examples of FDA submissions using RWE (real world evidence) and RWD (real world data). Gilead’s remdesivir was approved in 2020 for use in serious cases of COVID-19. During the submission process, Gilead included RWE findings. Data included adverse event identification and emergency use authorization data.
“One randomized controlled trial (RCT), ACTT-1 (NCT04280705, n=1,062) and two randomized, open-label trials—GS-US-540-5774 (NCT04292730, n=1,113) and GS-US-540-5773 (NCT04292899, n=4,891)—provided substantial evidence of efficacy. The applicant also submitted emergency use authorization (EUA) data, expanded access program data, and four additional studies (three RCTs and one open-label mass-balance study) as additional evidence of safety and efficacy.” Read more here.
(Source: Nick Honig & Tony Louder, Aetion, 3/16/21)
