- The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC. The other two studies include two P-II OLE studies (SIMPLE-Severe trial & SIMPLE-Moderate trial)
- ACTT-1 trial results: improvement in time to recovery in overall study population & in patients who required oxygen (10 vs 15days & 11 vs 18days); reduction in disease progression in patients needing oxygen, reduction in new mechanical ventilation or ECMO (13% vs 23%)
- Additionally, FDA also issued a new EUA for the use of Veklury to treat hospitalized pediatric patients aged <12yrs. weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to <40 kg with suspected or laboratory confirmed COVID-19 for whom use of an IV agent is clinically appropriate. Veklury is now the first and only approved COVID-19 treatment in the United States.
Click here to read full press release/ article | Ref: Gilead | Image: Los Angeles Times