Regeneron, Eli Lilly antibody treatments should no longer be used, FDA says


U.S. health officials say COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they are unlikely to work against the omicron variant.The Food and Drug Administration said Monday it is revoking emergency authorization for both drugs. If they prove effective against future variants, the FDA says it can reauthorize their use.The move was expected because both drugmakers had previously said their drugs are less effective against omicron.DeSantis blasts move as ‘sudden and reckless’Florida Gov. Ron DeSantis released a statement demanding the Biden administration reverse the decision.In a release from the governor, he called the decision “sudden and reckless.””Without a shred of clinical data to support this action, 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.”He demanded President Joe Biden reverse the decision.DeSantis said he believes the treatment can still help people.”The problem when you say that it’s not effective against omicron is we don’t think it’s been proven that, we think there’s indications that it’s not as effective as it was against delta, we’ve also had other people that have had gone and had their symptoms resolved,” he said.Florida Department of Health closes antibody treatment sitesThe Florida Department of Health announced they will be closing all monoclonal antibody treatment sites until further notice.The Florida Department of Health released a statement that read, in part: “Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice.”The state also said those who have appointments will be contacted directly about their cancellations.“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence. To date, such clinical evidence has not been provided by the United States Food and Drug Administration,” the release said.Regeneron has said it’s working on another drug, that will work on omicron. There are also other companies making antibody treatments, that do work but they are in extremely short supply. Health officials defend antibody treatment”We don’t know what the person has,” Seminole County Emergency Manager Alan Harris said.Harris says the county’s two clinics treat roughly 500 people a week and the vast majority are avoiding hospital trips. He also says it takes about four weeks for a lab to determine what strain of coronavirus has infected you. By then, you could be symptom and pain-free.However, Harris says waiting that long for a treatment that won’t harm you, even if it won’t necessarily help you, leaves no room for error if you do have a more serious strain.”If they have the delta variant then why not use something that is going to save their lives. So we’re going to use whatever we have to help save people’s lives,” Harris said.Recently purchased dosesFlorida Gov. Ron DeSantis has long been a major advocate for antibody treatments.The Sunshine State has recently received a new supply of 15,000 doses of Regeneron from the federal government.Early this year, DeSantis said he had to fight to get more doses of the treatment.”The federal government had stopped sending both Regeneron and the Eli Lilly monoclonal. It was based off of some preliminary study saying that it might not be as effective on omicron,” DeSantis said.The governor and surgeon general talked about how it is still unclear how effective this treatment is against omicron, but they don’t think the federal government should limit the supply.

U.S. health officials say COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they are unlikely to work against the omicron variant.

The Food and Drug Administration said Monday it is revoking emergency authorization for both drugs. If they prove effective against future variants, the FDA says it can reauthorize their use.

The move was expected because both drugmakers had previously said their drugs are less effective against omicron.

DeSantis blasts move as ‘sudden and reckless’

Florida Gov. Ron DeSantis released a statement demanding the Biden administration reverse the decision.

In a release from the governor, he called the decision “sudden and reckless.”

“Without a shred of clinical data to support this action, 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.”

He demanded President Joe Biden reverse the decision.

DeSantis said he believes the treatment can still help people.

“The problem when you say that it’s not effective against omicron is we don’t think it’s been proven that, we think there’s indications that it’s not as effective as it was against delta, we’ve also had other people that have had gone and had their symptoms resolved,” he said.

Florida Department of Health closes antibody treatment sites

The Florida Department of Health announced they will be closing all monoclonal antibody treatment sites until further notice.

The Florida Department of Health released a statement that read, in part: “Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice.”

The state also said those who have appointments will be contacted directly about their cancellations.

“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence. To date, such clinical evidence has not been provided by the United States Food and Drug Administration,” the release said.

Regeneron has said it’s working on another drug, that will work on omicron. There are also other companies making antibody treatments, that do work but they are in extremely short supply.

Health officials defend antibody treatment

“We don’t know what the person has,” Seminole County Emergency Manager Alan Harris said.

Harris says the county’s two clinics treat roughly 500 people a week and the vast majority are avoiding hospital trips. He also says it takes about four weeks for a lab to determine what strain of coronavirus has infected you. By then, you could be symptom and pain-free.

However, Harris says waiting that long for a treatment that won’t harm you, even if it won’t necessarily help you, leaves no room for error if you do have a more serious strain.

“If they have the delta variant then why not use something that is going to save their lives. So we’re going to use whatever we have to help save people’s lives,” Harris said.

Recently purchased doses

Florida Gov. Ron DeSantis has long been a major advocate for antibody treatments.

The Sunshine State has recently received a new supply of 15,000 doses of Regeneron from the federal government.

Early this year, DeSantis said he had to fight to get more doses of the treatment.

“The federal government had stopped sending both Regeneron and the Eli Lilly monoclonal. It was based off of some preliminary study saying that it might not be as effective on omicron,” DeSantis said.

The governor and surgeon general talked about how it is still unclear how effective this treatment is against omicron, but they don’t think the federal government should limit the supply.



Read More:Regeneron, Eli Lilly antibody treatments should no longer be used, FDA says

2022-01-25 12:05:00

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