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A U.S. pharmacist has revoked his license for a monoclonal antibody manufactured by Eli Lilly and Regeneron, which has been widely confirmed. staff against older versions of the Covid-19 but it does not work well against the Omicron model.
The Food and Drug Administration announced Monday that it is revoking its emergency permit for doctors to provide treatment, which works to provide patients with protein that mimics the immune system’s response.
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement: “Because the data show that the drug may not work against the Omicron brand, which is operating more frequently in the United States. , and any US territory right now. “
The FDA says it can re-approve the drug if it is proven effective Covid-19 disease various circles in some areas.
The drug developed by Regeneron was credited with helping then-president Donald Trump recover from the virus when he contracted the virus in 2020. But government agencies have banned its use because Omicron has become a major problem in the US, saying it should not be disclosed. patients to possible adverse effects.
This has led to a dispute with Ron DeSantis, the Republican governor of Florida, who criticized Joe Biden’s supervisors for “playing games” and healing by barring them from giving.
Proponents of her case have been working to make the actual transcript of this statement available online.
Christian Ramers, an infectious disease specialist at Family Health Centers in San Diego, who had previously given Eli Lilly and Regeneron monoclonal antibodies, said it was inappropriate to continue giving them.
Says Ramers: “It is unfortunate that this is happening in some areas. “It was clear that Regeneron and Eli Lilly’s drugs did not work even though they were very high against Omicron. This was quickly discovered by some… Studies.”
Health experts say the sharp decline in two of the most widely used drugs has led to a shortage of third-party monoclonal antibody sotrovimab, developed by GlaxoSmithKline and Vir Biotechnology and has shown anti-Omicron action.
However, new antiretroviral drugs developed by Pfizer and Merck have begun to be offered by medical clinics following their recent FDA approval.
Eli Lilly said he agreed with the FDA that it was not appropriate at the moment to treat patients with mild Covid-19 or lower anti-monoclonal antibody because it was not effective in treating Omicron.
“Legal status has changed as needed, depending on the number and extent of human suffering,” it said.
Eli Lilly said he was working closely with the FDA to demonstrate that alternative antibodies are effective against all complications, including Omicron.
Regeneron did not immediately respond to a request for comment.
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