Eli Lilly has been granted emergency use authorization by the FDA for its COVID-19 monoclonal antibody treatment, bebtelovimab.
This decision also comes shortly after another antibody cocktail developed by Lilly was banned by the agency after being shown ineffective against omicron. Bebtelovimab is different from previous antibody cocktails in that it’s considerably quicker to administer since the dosage is much smaller.
Bebtelovima, which is given as an intravenous injection over at least 30 seconds, has been authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients, age 12 and older, who are at high risk for severe disease, after the drug showed successful neutralization against omicron and all other variants of interest, including omicron’s emerging subvariant.
“With the emergence of variants such as omicron, treatment options remain limited,” Daniel Skovronsky, Lilly's chief scientific and medical officer said.
The authorization comes shortly after Eli Lilly announced a supply deal with the U.S. government. The $260m deal states that Lilly will provide 600,000 courses of treatment over the next two months. The government will also have the option to buy an additional 500,000 antibody courses.
“Should the BA.2 subvariant grow in proportion in the U.S., this potential treatment will help ensure that we can continue to offer a monoclonal antibody treatment that works against that strain of the virus,” the Department of Health & Human Services announced.
Lilly is also looking for approval for their Incyte-partnered rheumatoid arthritis drug, baricitinib, or Olumiant. According to Ricks, it has been shown to reduce the risk of death in late-stage patients by 46%.