Gilead's Remdesivir Receives the US FDA's Emergency Use Authorization for the Treatment of COVID-19
Shots:
- The EUA is based on two global P-III studies assessing 5-day & 10-day dosing durations of remdesivir (IV) vs PBO in patients with mod. to sev. symptoms of COVID-19- including those who are critically ill. Multiple additional clinical studies are ongoing to evaluate the safety and efficacy of remdesivir as a treatment for COVID-19
- Under EUA- the 10-day & 5-day dosing regimen is for the patients requiring & not requiring invasive mechanical ventilation and/or ECMO respectively. If a patient on the 5-day dosing regimen does not demonstrate clinical improvement after 5days- treatment may extend for up to 5 additional days
- The EUA will expedite broader use of remdesivir to treat hospitalized patients with severe COVID-19- enabling access to remdesivir at additional hospitals across the US
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Ref: Gilead | Image: Gilead
Related News: Gilead Reports Results of Remdesivir in P-III SIMPLE Studies for Patients with Severe COVID-19
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