Feds halt 2 COVID antibody drugs
The FDA says it has halted the use of COVID-19 antibody drugs made by Regeneron and Eli Lilly because they don’t work against the Omicron variant, which accounts for 99% of new US coronavirus cases.
Emergency authorization for the monoclonal antibody treatments was revoked by the federal Food and Drug Administration on Monday after the two pharmaceutical companies had said their drugs were less able to target Omicron because of its mutations.
The FDA said it is “highly unlikely” the antibodies would help people seeking treatment.
The FDA could reauthorize the treatments’ use if they prove effective against any new variants.
The drugs, which were purchased by the US government and have already been administered to millions of people with COVID, are laboratory-made versions of virus-blocking antibodies.
The treatment, which is not a substitute for the vaccine, is meant to prevent severe disease and death by supplying concentrated doses of one or two antibodies early on in infection.
Doctors have alternate therapies to battle early COVID-19 cases, including two new antiviral pills from Pfizer and Merck, but both are in short supply. An antibody drug from GlaxoSmithKline that remains effective is also in short supply.
Florida Gov. Ron DeSantis, who has heavily promoted antibody drugs and set up infusion clinics across the state, was quick to slam the regulatory move.
The Florida Department of Health shut down the state’s antibody clinics in the wake of the FDA’s announcement.
“Without a shred of clinical data to support this action, [President] Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” DeSantis said. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives.”