Eli Lilly's COVID-19 Antibody Bamlanivimab Granted FDA Emergency Use Authorization; 300,000 Vials to Be Delivered Within Two Months

According to a report by EO Healthcare on the 9th, the U.S. Food and Drug Administration (FDA) authorized Eli Lilly's developedCOVID-19NeutralizationAntibodyEmergency Use Authorization for bamlanivimab (LY-CoV555) for patients aged 12 years and older with mild to moderate COVID-19, who weigh at least 40 kg and are at high risk of progressing to severe disease and/or hospitalization, including individuals aged 65 years or older or those with certain chronic medical conditions.

The FDA’s Emergency Use Authorization states that the drug must be administered as soon as possible within 10 days of symptom onset in patients who test positive for SARS-CoV-2. The approved dosage is a single 700 mg intravenous infusion to be delivered over 60 minutes.

Image source: FDA official website

Following the news, Eli Lilly’s stock price jumped more than 3% in after-hours trading.

It is reported that this approval was based on an interim analysis of a Phase II clinical trial involving 465 non-hospitalized adult patients with COVID-19. Among these patients, 101 received a dose of 700 mg, 107 received a dose of 2,800 mg, 101 received a dose of 7,000 mg, and 156 received placebo.

The analysis results showed that among patients at high risk of disease progression, the mean rate of hospitalization and emergency department visits was 3% in those treated with bamlanivimab, compared to 10% in those receiving placebo. Among patients who received three different doses of bamlanivimab, the effects on viral load, reduction in hospitalization and emergency department visits, and safety were similar.

However, the antibody did not demonstrate significant efficacy in critically ill patients. In late October, Eli Lilly announced that it had halted volunteer enrollment for LY-CoV555, as the antibody was unlikely to help hospitalized COVID-19 patients recover from the advanced stages of the disease.

According to CNN, Eli Lilly has announced a $375 million agreement with the U.S. government for 300,000 vials of pendingEUABamlanivimab was delivered two months later. It is reported that Eli Lilly applied for an EUA for bamlanivimab last month, and the company had previously stated its plan to produce 1 million doses by the end of 2020 to provide free of charge to patients.

Notably, Regeneron’s COVID-19 neutralizing antibody cocktail therapy, REGN-COV2, sought FDA Emergency Use Authorization (EUA) at nearly the same time as Eli Lilly, but has not yet been approved.

This article is sourced from YiOu, an original piece by author Lin Yiling. For reprints or collaborations, please click here.Reprint Notice, unauthorized reproduction will be subject to legal action.