Shots:

• The approval is based on the P-III (ACTIV-2) trial to evaluate amubarvimab + romlusevimab in 847 patients aged 12-17yrs. with COVID-19 at high risk for progression to sev. disease, including hospitalization or death
• The final results showed an 80% reduction of hospitalization & death with fewer deaths @28 days & 78% in interim results, improvement in safety outcome in non-hospitalized COVID-19 patients, similar efficacy rates were observed in patients initiating therapy early (0-5 days) & late (6-10 days), following symptom onset
• The company plans to initiate further studies in China for amubarvimab/romlusevimab in immunocompromised populations as an additional measure of prophylaxis

 Ref: PR Newswire | Image: Brii Bio