Shots:

• The approval is based on the results from a P-III trial evaluating Ronapreve (casirivimab and imdevimab) in high-risk non-hospitalized patients with COVID-19
• The results showed a reduction in the risk of hospitalization or death by 70% in addition to the results from a P-I trial that demonstrated the safety- tolerability & PK in Japanese patients
• This marks the first time the Ab cocktail- known as REGEN-COV in the US and Ronapreve in other countries- has received a full approval to treat COVID-19

­ Ref:  Prnewswire | Image: Fierce Pharma