FDA halts use of antibody drugs that don't work vs. omicron [View all]
Source: NBC News
WASHINGTON — Covid-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they don’t work against the omicron variant that now accounts for nearly all U.S. infections, U.S. health regulators said Monday. The Food and Drug Administration said it was revoking emergency authorization for both drugs, which were purchased by the federal government and have been administered to millions of Americans with Covid-19. If the drugs prove effective against future variants, the FDA said it could reauthorize their use.
The regulatory move was expected because both drugmakers had said the infusion drugs are less able to target omicron because of its mutations. Still, the federal action could trigger pushback from some Republican governors who have continued promoting the drugs against the advice of health experts. Omicron’s resistance to the two leading monoclonal antibody medicines has upended the treatment playbook for Covid-19 in recent weeks.
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 also is in short supply. The FDA noted in its decision that omicron accounts for more than 99 percent of U.S. infections, making it “highly unlikely” the antibodies would help people now seeking treatment. The agency said restricting their use would also eliminate unnecessary drug side effects, including allergic reactions.
The U.S. government temporarily stopped distributing the two drugs in late December, as omicron was racing across the country to become the dominant variant. But officials resumed distribution after complaints from Republican governors, including Florida’s Ron DeSantis, who claimed that the drugs continued to help some omicron patients. DeSantis has heavily promoted antibody drugs as a signature part of his administration’s Covid-19 response, setting up infusion sites and lauding them at news conferences, while opposing vaccine mandates and other public health measures. Texas Gov. Greg Abbott has also launched state-sponsored infusion sites.
Read more: https://www.nbcnews.com/news/us-news/fda-halts-use-antibody-drugs-dont-work-vs-omicron-rcna13414
Heard this on the radio early this morning and then saw this -
by: Robert Pandolfino
Posted: Jan 24, 2022 / 10:24 PM EST / Updated: Jan 25, 2022 / 04:52 AM EST
TAMPA, Fla. (WFLA) – Governor Ron DeSantis is demanding the Biden Administration “reverse its sudden and reckless decision” to revoke emergency use authorization for Regeneron and Eli Lilly monoclonal antibody treatments. The Food and Drug Administration said it was revoking emergency authorization for both drugs, which were purchased by the federal government and have been administered to millions of Americans with COVID-19. If the drugs prove effective against future variants, the FDA said it could reauthorize their use.
The regulatory move was expected because both drugmakers had said the infusion drugs are less able to target omicron due to its mutations. Still, the federal action could trigger pushback from some Republican governors who have continued promoting the drugs against the advice of health experts. Omicron’s resistance to the two leading monoclonal antibody medicines has upended the treatment playbook for COVID-19 in recent weeks. 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 also is in short supply.
The U.S. government temporarily stopped distributing the two drugs in late December, as omicron was racing across the country to become the dominant variant. But officials resumed distribution after complaints from Republican governors, including Florida’s Ron DeSantis, who claimed that the drugs continued to help some omicron patients. DeSantis has heavily promoted antibody drugs as a signature part of his administration’s COVID-19 response, setting up infusion sites and lauding them at news conferences, while opposing vaccine mandates and other public health measures.
In a statement Monday evening DeSantis said the “abrupt and unilateral action by the Biden Administration will prevent access to lifesaving treatments for Floridians and Americans.” “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,” said Governor Ron DeSantis. “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.”
https://www.wfla.com/community/health/coronavirus/desantis-condemns-biden-admin-after-decision-to-revoke-eua-for-regeneron/
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