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Posted On: 04/26/2022 7:14:41 PM
Post# of 154867
The history
May 2020
CytoDyn seeks US FDA nod for design of late-stage study of coronavirus drug
Author Angelee Tabios
Theme Healthcare & Pharmaceuticals
CytoDyn Inc. said it will file a late-stage study protocol to the U.S. Food and Drug Administration for its experimental coronavirus medicine leronlimab.
The protocol will cover the factorial design of a phase 3 trial intended to evaluate the effectiveness of leronlimab compared to Gilead Sciences Inc.'s remdesivir in treating COVID-19, the respiratory disease caused by the new coronavirus. The study will also evaluate a combination of leronlimab and remdesivir, CytoDyn said in a press release.
Previously, leronlimab was used to treat more than 60 COVID-19 patients through an emergency investigational new drug authorization granted by the FDA. The eIND also allowed CytoDyn to initiate a phase 2b/3 study involving 390 patients and a mid-stage trial for individuals with mild to moderate COVID-19.
May 2020
CytoDyn seeks US FDA nod for design of late-stage study of coronavirus drug
Author Angelee Tabios
Theme Healthcare & Pharmaceuticals
CytoDyn Inc. said it will file a late-stage study protocol to the U.S. Food and Drug Administration for its experimental coronavirus medicine leronlimab.
The protocol will cover the factorial design of a phase 3 trial intended to evaluate the effectiveness of leronlimab compared to Gilead Sciences Inc.'s remdesivir in treating COVID-19, the respiratory disease caused by the new coronavirus. The study will also evaluate a combination of leronlimab and remdesivir, CytoDyn said in a press release.
Previously, leronlimab was used to treat more than 60 COVID-19 patients through an emergency investigational new drug authorization granted by the FDA. The eIND also allowed CytoDyn to initiate a phase 2b/3 study involving 390 patients and a mid-stage trial for individuals with mild to moderate COVID-19.
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