Gilead solidifies leadership in COVID-19 treatments with FDA remdesivir nod

• The FDA's full approval of Gilead Sciences' (NASDAQ:GILD) Veklury (remdesivir) on Thursday, October 22, for severely ill hospitalized COVID-19 patients was the first full nod for such a therapy and sustains the company's leadership position in antiviral treatments against SARS-CoV-2 infection. Remdesivir was also the first antiviral treatment to receive emergency use authorization (EUA) in the U.S., Europe, Canada, Australia and Japan to treat the respiratory infection.
• The company is actively working to expand the RNA polymerase inhibitor's indications. Its current U.S. EUA covers moderately ill patients and hospitalized pediatric patients under the age of 12 with certain weight restrictions.
• A search in ClinicalTrials.gov listed 23 ongoing or planned clinical trials on remdesivir.
• Four studies involve pediatric patients including a company-sponsored 52-subject Phase 2/3 study, CARAVAN, evaluating the drug in young people less than 18 years old. Primary endpoints are safety and pharmacokinetics. Secondary endpoints include efficacy measures. The estimated completion date is February 2021.
• Gilead is also sponsoring a 1,230-subject Phase 3 trial assessing remdesivir's effect on reducing the rate of hospitalization or death in outpatients as young as 12 years old with COVID-19. The primary endpoints are safety and the proportion of hospitalizations or death by day 14. The primary completion date is December.
• Yet another company-sponsored trial is a 282-subject Phase 1/2 evaluating an inhalable formulation of the antiviral in adult healthy volunteers (first part) then adult patients with early-stage infection. The primary endpoint of the second part is the time-weighted average change from baseline in SARS-CoV-2 viral load at day 7. The estimated completion date is also December.
• Another key study, sponsored by Roche (OTCQX:RHHBY), is a 450-subject Phase 3 trial, REMDACTA, assessing remdesivir plus Actemra (tocilizumab) compared to placebo plus tocilizumab in hospitalized patients as young as 12 years old with severe COVID-19. The primary endpoint is clinical status at day 28. The estimated completion date is December 1.
• NIH's National Institute of Allergy and Infectious Diseases (NIAID) is conducting two adaptive late-stage studies, ACTT-2, assessing the combination of remdesivir and Eli Lilly's (NYSE:LLY) Olumiant (baricitinib) compared to remdesivir alone in adult hospitalized patients and ACTT-3, evaluating remdesivir plus interferon beta-1a compared to remdesivir alone. The estimated completion dates are August 2023 and November 2023, respectively. It is also conducting two others: Phase 2 ACTIV-5/BET-A assessing remdesivir + AbbVie's (NYSE:ABBV) risankizumab in hospitalized adults and Phase 2 ACTIV/BET-B assessing remdesivir + Humanigen's (NASDAQ:HGEN) lenzilumab in hospitalized adults.
• https://seekingalpha.com/news/3625261-gilead-solidifies-leadership-in-covidminus-19-treatments-fda-remdesivir-nod