Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation firstname.lastname@example.org
SPECIAL REPORT #20.13
Remdesivir meets primary endpoint in pivotal COVID-19 study
Gilead announces that the pivotal, placebo-controlled study of remdesivir conducted at the National Institute of Allergy and Infectious Diseases (NIAID) had met its primary endpoint. The company also released data from their open-label Phase III study showing little difference in patient response whether they received remdesivir for either 5 days or 10 days.
In the study, the time to clinical improvement for 50 % of patients was 10 days, in the 5-day treatment group and 11 days in the 10-day treatment group. More than half of patients in both treatment groups were discharged from the hospital by Day 14 (5-day: 60.0%, n=120/200 vs.10-day: 52.3% n=103/197; p=0.14). At Day 14, 64.5 percent (n=129/200) of patients in the 5-day treatment group and 53.8 percent (n=106/197) of patients in the 10-day treatment group achieved clinical recovery.
Gilead expects an accelerated approval from the US FDA.
We will report more as we get access to additional information expected to be released by the NIAID in an upcoming briefing.
Paris, April 29, 2020
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