FDA clears new monoclonal antibody treatment to fight omicron | Connect FM | Local news radio

(WASHINGTON) – The Food and Drug Administration has authorized a new monoclonal antibody treatment for COVID-19 that is resistant to the omicron variant and the BA.2 subvariant.

The drug, called Eli Lilly’s bebtelovimab, is a monoclonal therapy for COVID-19 patients as young as 12 who are at high risk of getting seriously ill and who have recently been infected, to prevent them from getting even sicker and keep them from the hospital.

The clearance comes after months of explosive spread of the omicron variant that squeezed an already limited arsenal of COVID-19 drugs.

Lilly’s previous monoclonal treatment was one of two the government bought in bulk that failed against omicron, leaving the federal government scrambling to source functional omicron therapies. Meanwhile, treatments that have proven effective against omicron are few and far between, forcing tough choices about which patients in need should get this limited supply.

On the eve of the authorization, the Biden administration announced that it had purchased 600,000 doses of bebtelovimab for at least $720 million. The plan is to release around 300,000 doses this month and another 300,000 in March. The contract also includes a future option for an additional 500,000 doses, if needed.

The clearance brings the number of treatments for omicron in the United States to four, although production continues to increase. Other options include monoclonal therapy sotrovimab, from Vir Biotechnology and GlaxoSmithKline; and two antiviral pills, Paxlovid from Pfizer and Molnupiravir from Merck.

Daniel Skovronsky, chief scientific and medical officer of Eli Lilly and president of their research labs, said in an interview with ABC News that the company began working on the therapy more than a year ago – long before the emergence of omicron – hoping to be “future proof”. for a range of variants and anything else that might come down the road.

It was an “emergency glass-breaking” solution, Skovronsky said.

But once the new variant became widespread, against which basic treatments failed, it suddenly became critical to get a new one authorized.

“Once the omicron was identified, there was an urgent need to make sure this antibody worked against it and to work with the government to try to make it available to patients as quickly as possible,” Skovronsky said. “It’s an unusual situation where you’re trying to fight a disease that in some sense doesn’t exist yet. … We can’t protect ourselves from something entirely new that the world has never seen before.

Lilly’s new drug is cleared for administration by intravenous injection by a healthcare provider — a notable change from the strenuous, hours-long infusion that accompanied previous monoclonal antibodies, a process that requires a lot of clinical staff. It should be administered within seven days of the onset of symptoms.

“Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we seek to further increase supply,” said Dr. Patrizia Cavazzoni, director of the Center for Drug FDA’s Evaluation and Research, in a statement, calling the new emergency use authorization “an important step in addressing the need for more tools to treat patients as new variants of the virus continue to emerge” .

“We’re already working on next-generation antibodies, looking for things that bind in different ways than bebtelovimab, so if that’s ultimately defeated by viral mutants, we’ll have something else to offer,” Skovronsky said. . “You have to stay ahead of this virus.”

Eric M. Strauss and Anne Flaherty of ABC News contributed to this report.

Copyright © 2022, ABC Audio. All rights reserved.

Comments are closed.