FDA halts use of antibody drugs that don't work vs. omicron
Source: NBC News
WASHINGTON Covid-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they dont 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. Omicrons 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 Floridas 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 administrations 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. Omicrons 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 Floridas 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 administrations 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 Bidens 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/
Ligyron
(7,632 posts)IOW, He Wants people to get sick so they have to use the drugs manufactured by his buddies and owned by their stockholders.
Cares less if they die or not as long as they use those expensive, often ineffective drugs the PTB sell.
muriel_volestrangler
(101,312 posts)... less able to target omicron". DeSantis just lies, because he knows the Republican base is stupid enough to believe whatever he says, if it fits their feelings.
IronLionZion
(45,438 posts)and reject stuff that is proven to work
BumRushDaShow
(128,937 posts)By BRENDAN FARRINGTON August 18, 2021
Florida Gov. Ron DeSantis who has been criticized for opposing mask mandates and vaccine passports is now touting a COVID-19 antibody treatment in which a top donors company has invested millions of dollars. DeSantis has been flying around the state promoting a monoclonal antibody treatment sold by Regeneron, which was used on then-President Donald Trump after he tested positive for COVID-19.
The governor first began talking about it as a treatment last year. Citadel, a Chicago-based hedge fund, has $15.9 million in shares of Regeneron Pharmaceutical Inc., according to filings with the U.S. Securities and Exchange Commission. Citadel CEO Ken Griffin has donated $10.75 million to a political committee that supports DeSantis $5.75 million in 2018 and $5 million last April.
(snip)
Texas Gov. Greg Abbott tested positive for COVID-19 on Tuesday and is receiving Regeneron treatments. Like DeSantis, he has been opposed to mask mandates in public schools. He was vaccinated in December.
(snip)
And while DeSantis has had a very public war of words with Democratic President Joe Biden about requiring masks in schools and other virus precautions, they both encourage monoclonal antibody treatments. A Regeneron treatment costs more than $1,000, while a vaccine costs about $25.
https://apnews.com/article/joe-biden-business-health-coronavirus-pandemic-4d0d18b24e0dd41de2424e19b3ed994f
IronLionZion
(45,438 posts)they make a lot of bad investments
Alexander Of Assyria
(7,839 posts)Science and therefore must hate it with all their might by default. As commanded by Fox.
Forgive them for they know not what they do
fk that
sorry.
lark
(23,099 posts)This is 100% about rw politicians betting the state $$ on a failed bet and panicking because lots more will die without the Sotovirib which he didn't buy and the Regeneron is mostly useless.
Death Sentence is totally exposed for the fraud he is and he's terrified folks will get revenge on him and GOP so of course blaming Dems.