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(CNN) —Federal regulators are considering limiting the approval of certain monoclonal antibody therapies that have not proven effective against the omicron variant of coronavirus, more information in the decision. The source told CNN.
Sources say the U.S. Food and Drug Administration may decide to take steps to curb the use of antibody treatments produced by Eli Lilly and Regeneron in the coming days, their monoclonal therapy is effective. An omicron variant of the virus that points to increased evidence that it is not neutralized.
The National Institutes of Health recently updated its guidelines to advise clinics not to use these treatments for patients with mild to moderate COVID-19 due to their reduced efficacy against Omicron variants. ..
Last week, senior government health officials, including Dr. David Kessler, Chief Science Officer of the White House’s COVID Response Team, and Assistant Director of Health Rachel Levine, called the Governor and State Health Authority offices. They urged opposition to using these treatments at Omicron, which currently describes almost all positive cases, a source familiar with the phone said.
The Centers for Disease Control and Prevention estimates that more than 99% of cases nationwide carry the Omicron variant.
Treatments, despite recent data, continue to be popular with some governors who continue to promote treatments. In the last two weeks, the state has distributed nearly 110,000 treatments for Lily and Regeneron, according to a federal database maintained by the Department of Health and Human Services.
Earlier this month, in a record surge in new coronavirus cases in Florida, Governor Ron DeSantis raided the Biden administration for suspending the shipment of monoclonal antibodies, and said treatment would remain widely available. I promoted it.
At a press conference on January 3, DeSantis claimed that his administration had seen treatment for patients with Omicron, but provided no further evidence.
“Omicron isn’t the only variant out there,” DeSantis said. “And that’s what we saw actually applied to Omicron patients, and we saw the symptoms go away.”
According to the CDC, since the week of December 19, Omicron has accounted for more than 95% of cases in the southern United States. Regeneron publicly states that its monoclonal antibody therapy is not effective against Omicron variants.
In Florida, about 13,000 regenerons have been used in the last two weeks, more than the combined amount of the other three states. DeSantis’ office did not immediately respond to a request for comment on Saturday.
DeSantis often uses monoclonal antibodies as the basis for his response to the proliferation of coronavirus cases in his state and is often more aggressive than vaccines. Last summer he introduced a new clinic where individuals can be treated at the onset of symptoms or at the time of exposure to a person with COVID-19. His press conferences often feature direct reports of people who have recovered from the coronavirus after receiving treatment.
Other states followed the leadership of DeSantis. Texas Governor Greg Abbott last year opened a state-sponsored “infusion center” where COVID-positive patients can receive monoclonal antibody therapy. Abbott himself received monoclonal antibody therapy with regenerone when he tested positive for coronavirus in August, when the delta mutant was predominant.
The rapidly prevalent subspecies of Omicron was first detected in the United States on December 1st and soon became the predominant subspecies.
The Biden administration has agreed to offer regeneron and lily treatment shipments in the weeks that follow, while the delta is declining but remains a variant. The likelihood of positive results in a small proportion of Delta patients was calculated as a trade-off with the potential to provide ineffective treatment to Omicron patients, officials said. Most cases of coronavirus are not sequenced to determine mutations, and physicians often make treatment decisions without knowing which chain of the virus the patient is infected with.
However, the Biden administration wanted most states to move away from monoclonal antibody therapy, as Delta now accounts for a very small proportion of cases in most areas, officials said.
There is also concern that the widespread use of treatments may expose people to the unnecessary risk of side effects from the administration of monoclonal antibodies. According to the National Institutes of Health, some patients report rashes, diarrhea, nausea and dizziness after treatment. A few patients had a severe allergic reaction.
The Byden administration is centered on other therapies that have shown greater efficacy against Omicron variants, including Merck and Pfizer antivirals, GlaxoSmithKline monoclonal antibodies, AstraZeneca pre-exposure prophylaxis, and over-the-counter remdesivir. I’m asking the state to move.
On Friday, the US Food and Drug Administration extended the use of antiviral remdecibir for the treatment of mild to moderate COVID-19 to children and non-hospitalized people.
The FDA is considering limiting the approval of certain monoclonal antibody therapies for COVID-19 | Chicago News
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