US authorizes new antibody drug to fight omicron
WASHINGTON — U.S. well being regulators on Friday approved a new antibody drug that targets the omicron variant, a key step in restocking the nation’s arsenal towards the most recent model of COVID-19.
The Meals and Drug Administration mentioned it cleared the Eli Lilly drug for adults and adolescent sufferers with mild-to-moderate circumstances of COVID-19. Lilly introduced work on the remedy late final yr after testing revealed that its earlier antibody remedy was ineffective towards the dominant omicron variant.
The Biden administration has bought 600,000 doses earlier than the authorization and can start delivery preliminary provides to state well being authorities for distribution.
It is “an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge,” mentioned Dr. Patricia Cavazzoni, FDA’s drug heart director.
The FDA announcement comes after the 2 main monoclonal antibody therapies within the U.S. turned out to be ineffective towards omicron. Knowledge point out the Lilly drug additionally works towards the rising BA.2 mutation of omicron.
Lilly mentioned the contract for its new drug — bebtelovimab, pronounced “beb-teh-LO-vi-mab” — is value at the least $720 million.
Laboratory-made monoclonal antibodies stand in for the human physique’s immune system by performing to block an invading virus. Delivered by IV or by injection, the medicines are meant to be used early in an an infection.
However late final month the FDA revoked its emergency use authorization for Regeneron’s antibody drug, together with Lilly’s. The 2 medicines had been the the spine of antibody remedy, and medical doctors have been laborious pressed to give you fallbacks after they didn’t work towards omicron.
Alternate therapies, together with antiviral drugs from Pfizer and Merck, have been in brief provide. An antibody drug from GlaxoSmithKline that continues to be efficient towards omicron can also be scarce.
Scientists say COVID-19 therapies like monoclonal antibodies will not be an alternative choice to vaccination.
Underneath the U.S. contract with Lilly, the federal government will obtain about 300,000 remedy programs of the new antibody drug in February and one other 300,000 in March.
The Related Press Well being and Science Division receives assist from the Howard Hughes Medical Institute’s Division of Science Training. The AP is solely answerable for all content material.