US FDA Grants Emergency Use Authorization for Antibody Treatment Administered to Trump (Comprehensive)

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Seungjin Lee] The COVID-19 antibody treatment developed by the American biotechnology company Regeneron, which was used in the treatment of U.S. President Donald Trump’s COVID-19 infection, has received emergency use authorization from the U.S. Food and Drug Administration (FDA).

According to local media such as Bloomberg and The Wall Street Journal (WSJ) on the 21st (local time), the FDA approved the emergency use of Regeneron's antibody treatment 'REGN-COV2.'

The FDA authorized the emergency use of 'REGN-COV2' for the treatment of COVID-19 patients aged 12 and older who exhibit mild to moderate symptoms, including high-risk groups aged 65 and above.

According to the FDA, clinical trials involving COVID-19 infected patients showed that high-risk patients treated with this drug had a reduced rate of hospitalization or emergency room visits due to COVID-19 symptoms within 28 days of starting treatment compared to the placebo control group.

The FDA stated that the safety and efficacy of this therapy for COVID-19 treatment will continue to be evaluated.

'REGN-COV2' is a therapeutic drug combining two monoclonal antibodies, developed by analyzing and evaluating antibodies from the blood of recovered COVID-19 patients and selecting only those capable of neutralizing the virus for therapeutic use.

This drug previously gained public attention as it was used in President Trump's COVID-19 treatment.

The Washington Post (WP) reported that this is the second monoclonal antibody treatment to receive FDA approval.

Earlier, the FDA granted emergency use authorization on the 9th for the monoclonal antibody treatment 'LY-CoV555,' developed by U.S. pharmaceutical company Eli Lilly in collaboration with Canadian biotechnology firm AbCellera, for use in mild COVID-19 patients.

The treatment is intended for patients who have not yet been hospitalized but are at high risk of becoming severe cases due to age (65 and older or 12 and younger) or other factors.

However, recent clinical trials targeting severe COVID-19 patients conducted by Lilly and Regeneron were halted, raising global doubts about the treatment’s effectiveness and safety.

The WP reported that, like Lilly’s antibody treatment, Regeneron’s antibody treatment may face supply shortages due to the lengthy manufacturing process.

Regeneron announced earlier this month that it expects to produce enough doses for 80,000 patients by the end of this month and plans to increase production to doses for 300,000 patients by the end of January next year.

This content was produced with the assistance of AI translation services.