Home FDA Restricts Use of Regeneron and Lilly/Junshi COVID-19 Monoclonal Antibodies Due to Omicron Ineffectiveness

FDA Restricts Use of Regeneron and Lilly/Junshi COVID-19 Monoclonal Antibodies Due to Omicron Ineffectiveness

Jan 25, 2022 10:22 CST Updated 10:22
Regeneron

Biopharmaceutical Manufacturer

Eli Lilly

Global Pharmaceutical R&D and Production Company

Junshi Biosciences

Innovative Drug Developer

GSK

Pharmaceutical R&D Manufacturer

Vir Biotechnology

Developer of Immunological Drugs

FDA

U.S. Food and Drug Administration

On January 24, 2022, the FDA announced that it would restrict the use of Regeneron and Eli Lilly/Junshi Biosciences' COVID-19 neutralizing antibodies because they are ineffective against the Omicron variant. They can only be used for variants that are sensitive to these COVID-19 neutralizing antibodies, such as Delta. Since GSK/Vir Biotechnology's Sotrovimab remains effective against Omicron, its use has not been restricted.

The table below shows the distribution numbers of COVID-19 neutralizing antibodies and oral medications. Previously, the distribution speeds of neutralizing antibodies from Regeneron, Eli Lilly/Junshi Biosciences, GSK/Vir Biotechnology, and AstraZeneca were similar. With the prevalence of Omicron, market share will shift towards drugs like Sotrovimab. Additionally, the distribution speed of oral COVID-19 medications will soon surpass that of neutralizing antibodies. Due to differences in mechanisms of action, Pfizer's and Merck's oral drugs are unaffected by mutant strains. Small-molecule oral drugs have inherent advantages in terms of administration convenience, production cost, and scalability.

The CDC estimates that by January 15, 2022, the Omicron variant accounted for over 99% of cases, which is the key reason for adjusting the distribution of neutralizing antibodies.

Summary

Although new variants of the coronavirus continue to emerge, current evidence shows that the broad-spectrum neutralizing antibodies developed by Vir Biotechnology and Brii Biosciences are effective against all major variants. Oral medications for COVID-19 with different mechanisms of action also provide crucial tools in combating these variants.