FDA halts Regeneron, Eli Lilly monoclonal antibody COVID drugs

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FDA halts Regeneron, Eli Lilly monoclonal antibody COVID 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.

Emergency authorization for the monoclonal antibody treatments was revoked by the federal Food and Drug Administration on Monday after the two pharmaceutical companies had said their drugs were less able to target Omicron because of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.

With Omicron accounting for more than 99 percent of coronavirus cases in the US, 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 potential future variants, the health regulators said.

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.

nurse and patient
The FDA has halted the use of Eli Lilly and Regeneron monoclonal antibody treatments because they are not effective against the Omicron variant.
Los Angeles Times via Getty Imag

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. 

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, calling it a “sudden and reckless decision.”

The Florida Department of Health shut down the state’s antibody clinics in the wake of the FDA’s announcement.

IV drip
Florida’s Department of Health closed all the state’s antibody clinics following the FDA’s announcement.
Bloomberg via Getty Images

“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 in a statement.

“This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives. There are real-world implications to Biden’s medical authoritarianism — Americans’ access to treatments is now subject to the whims of a failing president.”

The government had temporarily stopped distributing the two drugs in late December but resumed distribution following backlash from DeSantis and other GOP governors, who claimed the treatments were still helping some Omicron patients.

Healthcare worker
Antibody treatment works by injecting a concentrated amount of lab-made antibodies early on in the COVID-19 infection, which prevents the most severe symptoms. It is not a replacement for the vaccine.
Bloomberg via Getty Images

Texas Gov. Greg Abbott also launched state-sponsored infusion sites to distribute the antibody drugs.

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.

Both Regeneron and Lilly previously announced they were developing new antibodies that specifically target Omicron.

The move to halt Regeneron’s and Lilly’s antibody drugs comes just days after regulators broadened the use of remdesivir — the first drug approved for COVID-19 — to treat more patients.

The FDA on Friday expanded the antiviral’s approval to include adults and children with early COVID-19 who face a high risk of ending up in the hospital.

Remdesivir, which requires three consecutive IV infusions over three days, had previously been limited to those in the hospital.

With Post wires

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