Positive Phase III data for regdanvimab monoclonal antibody treatment for mild- to- moderate symptoms of COVID-19
Phase III study (n=1,315) showed regdanvimib reduced risk of hospitalisation/death by 72% for pts at high-risk of progressing to severe COVID-19 to day 28 [3.1 vs 11.1 %; p< 0.0001] and reduced risk of hospitalisation/death by 70% in all pts [2.4 vs 8.0 %, p < 0.0001] vs placebo.
Source:
Biospace Inc.
SPS commentary:
CHMP has issued a positive scientific opinion recommending regdanvimab as a treatment option for patients at high risk of progressing to severe COVID-19, based on reasonable likelihood that the medicine may provide clinical benefit and a low likelihood of harm.