Remdesivir given full approval by the US FDA, but on limited data
11 November 2020. Related: COVID-19: investigational drugs, COVID-19.
Simon Collins, HIV i-Base
On 22 October 2020 the US FDA approved remdesivir as an antiviral treatment for COVID-19 in adults and children >12 years old, weighing at least 40 kgs. [1]
Approval was based on results from three randomised, controlled clinical trials that included patients hospitalised with mild-to-severe COVID-19. These were the NIAID ACTT-1 study (n=1062) and two phase 3 Gilead studies (GS-US-540-5773 and GS-US-540-5774). [2]
ACTT-1 reported a faster median recovery compared to placebo (10 vs 15 days) in 1062 participants. Updated (and full) results from this study were also recently published in the NEJM. [3]
GS-US-540-5773 reported improved symptoms after 5-day treatment but not from 10-day treatment, each compared to standard of care in 582 participants.
GS-US-540-5774 reported similar results at day 14 in 392 participants randomised to either 5-day or 10-day treatment.
However, this wasn’t the regular FDA full review as studies that have reported negative findings were not included (for example, the early Chinese RCT published by Wang et al in the Lancet, or the more recent WHO SOLIDARITY study) – a point that has already been highlighted in other reports. [4]
Approval was based on Fast Track and Priority review status.
Remdesivir was previously approved under an Emergency Use Authorization (EUA) on 1 May 2020.
Remdesivir is manufactured and distributed by Gilead Sciences with the tradename Veklury.
References
- FDA. FDA Approves First Treatment for COVID-19. (22 October 2020).
https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19 - Combined cross discipline summary review. (21 October 2020).
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214787Orig1s000Sumr.pdf (PDF) - Beigel JH et al. Remdesivir for the treatment of Covid-19 — Final Report. NEJM, DOI: 10.1056/NEJMoa2007764. (8 October 2020).
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764 - Cohen J. The ‘very, very bad look’ of remdesivir, the first FDA-approved COVID-19 drug. Science. doi:10.1126/science.abf4549.
https://www.sciencemag.org/news/2020/10/very-very-bad-look-remdesivir-first-fda-approved-covid-19-drug
This report was first posted on 29 October 2020.