FDA Has Good News For People At High Risk For The Omicron COVID-19 Variant
For those who are most susceptible to COVID-19 infection, the use of monoclonal antibody therapy has helped not only treat the virus but reduce the likelihood for the development of severe symptoms and hospitalizations, according to Houston Methodist Hospital. However, in late January, the U.S. Food & Drug Administration (FDA) restricted the use of two monoclonal antibody treatments from Regeneron and Eli Lilly (via NBC News). The decision was made after research revealed the drugs to be ineffective in treating the rampant Omicron variant.
Now, the FDA has authorized the emergency use of a new monoclonal antibody drug from Eli Lilly that has proven effective against the Omicron variant (per HealthDay). This particular drug is designed to treat "mild-to-moderate COVID-19 in adults and pediatric patients at least 12 years of age who are at high risk for severe disease." This welcome news comes at a time when monoclonal antibody treatments have been scarce throughout the country during January.
Emergency use authorization gets FDA approval
Addressing the recent scarcity of monoclonal antibody treatments, the director of the FDA Center for Drug Evaluation and Research, Dr. Patrizia Cavazzoni, tells HealthDay, "Today's action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply. This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge."
In clinical studies involving over 700 COVID-19 positive patients, researchers found that those who received Lilly's monoclonal antibody drug, bebtelovimab, had reduced rates of death and hospitalizations compared to the control group that received a placebo drug (via HealthDay). Side effects included rash, itching, infusion-related reactions, nausea, and vomiting.
Eli Lilly will be providing the U.S. government with 600,000 doses of the drug. Lilly's chief scientific and medical officer and president of Lilly Research Laboratories, Daniel Skovronsky, comments on the positive impact this drug will have for those in need stating, "With the emergence of variants such as Omicron, treatment options remain limited. Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and health care providers who continue to battle this pandemic."