FDA Grants Emergency Use Authorization to Eli Lilly’s Bebtelovimab for Mild-to-Moderate COVID-19 with Full Neutralizing Activity Against Omicron Variant

News on February 16, 2022 /BioValleyBIOON/ -- Recently, the U.S. Food and Drug Administration (FDA) GrantEli Lilly(Eli Lilly) Monoclonal Antibody Drug Bebtelovimab Emergency Use Authorization (EUA):For the treatment of patients with mild to moderate COVID-19 who are aged ≥12 years, weigh ≥40 kg, have tested positive for direct SARS-CoV-2 virus, and are at high risk of progressing to severe COVID-19 (including hospitalization and death).

The authorized dose of bebtelovimab is 175mg, administered via a single intravenous injection (over at least 30 seconds). Bebtelovimab should be administered as soon as possible within 7 days after the onset of symptoms, following a positive direct SARS-CoV-2 viral test result. The product is supplied in a 175mg/2mL single-dose vial.

Currently, bebtelovimab is being studied as a monotherapy and in combination with other monoclonal antibodies for the treatment of mild to moderate COVID-19. Bebtelovimab was discovered by scientists at AbCellera and the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID).Eli LillyHas been authorized and developed bebtelovimab.

FDAThe EUA for bebtelovimab was granted based on data from the Phase 2 BLAZE-4 trial (NCT04634409). This trial evaluated the efficacy and safety of bebtelovimab in non-hospitalized patients with mild to moderate COVID-19. In the trial, patients received a single intravenous infusion of bebtelovimab 175mg as monotherapy or in combination with bamlanivimab 700mg and etesevimab 1400mg.

Among the 380 low-risk patients enrolled in the placebo-controlled portion of the trial, treatment with bebtelovimab shortened the time to sustained resolution of symptoms compared to placebo. The median time to sustained symptom resolution was 8 days (95% CI: 7-9) for the placebo group, compared to 6 days (95% CI: 5-7; p=0.003) for the bebtelovimab monotherapy group and 7 days (95% CI: 6-8; p=0.289) for the bebtelovimab combination therapy group. A reduction in viral load was also observed on Day 5 post-treatment compared to placebo.

In the trial's randomized open-label portion, 150 high-risk patients received a single infusion of bebtelovimab monotherapy or combination therapy with etesevimab and bamlanivimab. The evaluation of COVID-19-related hospitalization or all-cause death in patients continued up to Day 29. Results showed that events occurred in 2 patients in the combination therapy group and 3 patients in the bebtelovimab monotherapy group. One patient receiving bebtelovimab monotherapy died on Day 34. The median time to sustained symptom resolution for patients receiving bebtelovimab monotherapy was 7 days.

In the non-randomized, open-label portion of the trial, 176 high-risk patients received a single infusion of bamlanivimab, etesevimab, and bebtelovimab. The evaluation of COVID-19-related hospitalization or all-cause mortality in patients continued until Day 29. The results showed that events occurred in three patients, with no deaths reported. The median time to sustained symptom resolution was 8 days.

BLAZE-4 was conducted before the emergence of the Omicron variant; no patients in the study were infected with the Omicron lineage or sub-lineage viruses. However, non-clinical viral neutralization data show that bebtelovimab maintains full neutralizing activity against Omicron and all other known variants of interest and concern, including BA.2.

The most common adverse reactions of bebtelovimabAdverse ReactionsFor infusion-related reactions (0.3%), pruritus (0.3%), and rash (0.8%). Treatment with bebtelovimab may also be associated with serious hypersensitivity reactions, including anaphylaxis. (Bioon.com)

Source of Original Text:Coronavirus (COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant