Therapeutics

The spectrum of medical therapies to treat coronavirus disease 2019 (COVID-19) is growing and evolving rapidly, including both drugs approved by U.S. Food and Drug Administration (FDA) and drugs made available under FDA emergency use authorization (EUA). COVID-19.

Current clinical management of COVID-19 consists of infection prevention and control measures and supportive care, including supplemental oxygen and mechanical ventilatory support when indicated. FDA has approved one drug, remdesivir (Veklury), for the treatment of COVID-19 in hospitalized patients aged 12 years and older who weigh at least 40 kg.

Early effective treatment of any disease can help avert progression to more serious illness, especially for patients at high risk of disease progression and severe illness, with the additional benefit of reducing the burden on healthcare systems. A number of novel therapeutics (e.g., monoclonal antibodies) are available under EUA for early outpatient treatment. Trials to assess the potential effectiveness of these therapeutics in outpatients at high risk of disease progression are ongoing.

More than a year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.

Regulators around the world have allowed a handful of treatments to be used on an emergency-use basis including Eli Lilly and Company's monoclonal antibodies bamlanivimab with etesevimab; Regeneron's casirivimab and imdevimab; GlaxoSmithKline/Vir Biotechology's sotrovimab; Roche's Actemra; Celltrion's Regkirona; and convalescent plasma.

Several large international trials are underway. The largest, SOLIDARITY, is led by the World Health Organization (WHO). More than 100 countries have joined SOLIDARITY to evaluate high-profile treatment candidates for COVID-19.

This tracker will be updated biweekly with the latest in developments for treatment candidates who have advanced to at least Phase 1 study.