Shots:
The US FDA has approved Olumiant for COVID-19 in hospitalized adults who required supplemental oxygen, invasive/non-invasive mechanical ventilation, or ECMO for 14 days or until hospital discharge
The approval was based on 2 P-III (ACTT-2) & (COV-BARRIER) studies including (COV-BARRIER OS 7 addendum) study to evaluate Olumiant (4mg, qd). The findings revealed that there were no additional safety signals associated with the usage of Olumiant
Olumiant is the 1st JAK inhibitor & has been available in the US under a EUA since Nov 2020. Lilly has submitted the applications to multiple regulatory agencies globally for approval or authorization with expected regulatory decisions shortly
Ref: PRNewswire | Image: Lilly
