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FDA considers limiting authorization of certain monoclonal antibody treatments


CNN

By Steve Contorno, CNN

Federal regulators are considering limiting the authorization of certain monoclonal antibody treatments that have not proved effective against the Omicron variant of the coronavirus, a source familiar with the decision-making told CNN.

The US Food and Drug Administration could decide in the coming days to take steps to curb the use of antibody treatments produced by Eli Lilly and Regeneron, the source said, pointing to the growing body of evidence that shows their monoclonal therapies don’t effectively neutralize the virus’ Omicron variant.

The National Institutes of Health had recently updated its guidelines to advise clinics against using these treatments on patients with mild to moderate Covid-19 due to their diminished effectiveness against the Omicron variant.

This past week, senior health officials in the administration, including Dr. David Kessler, chief science officer of the White House’s COVID Response Team, and assistant secretary for Health Dr. Rachel Levine, called the offices of governors and state health officials. They urged against using these treatments with Omicron now accounting for nearly all positive cases, a source familiar with the calls said.

The Centers for Disease Control and Prevention estimates more than 99% of cases nationwide have the Omicron variant.

The treatments have remained popular among some governors, who continue to push them despite the recent data. Over the last two weeks, states have distributed nearly 110,000 doses of the Lily and Regeneron treatments, according to a federal database maintained by the Department of Health and Human Services.

Earlier this month, amid a record-breaking surge of new coronavirus cases in Florida, Gov. Ron DeSantis assailed the Biden administration for pausing shipments of the monoclonal antibodies, and has pushed for the treatment to remain widely available.

During a January 3 press conference, DeSantis contended his administration had seen the treatments work on Omicron patients, though he didn’t provide further evidence.

“Omicron is not the only variant that’s out there,” DeSantis said. “And it’s something that we actually have seen applied with Omicron patients and we have seen symptoms resolved.”

Omicron has accounted for more than 95% of cases in the Southern region of the US since the week of December 19, according to the CDC. Regeneron has publicly stated its monoclonal antibody treatment is not effective against the Omicron variant.

Nearly 13,000 doses of Regeneron were used in Florida over the past two weeks, more than any three other states combined. DeSantis’ office did not immediately respond to a request for comment on Saturday.

DeSantis has made monoclonal antibodies a cornerstone of his response to surges of coronavirus cases in his state, often pushing the treatment more vigorously than vaccines. Last summer, he introduced new clinics where individuals could receive the treatment at the onset of symptoms or exposure to someone with Covid-19. His news conferences often feature first-hand accounts of people who have recovered from coronavirus after receiving treatment.

Other states followed DeSantis’ lead. Texas Gov. Greg Abbott last year opened state-sponsored “infusion centers” where Covid-positive patients could receive monoclonal antibody treatment. Abbott himself received Regeneron’s monoclonal antibody therapy treatment when he tested positive for coronavirus in August when its Delta variant was predominant.

The fast-spreading Omicron variant was first detected in the US on December 1, and quickly became the predominant variant.

The Biden administration agreed to provide shipments of the Regeneron and Lily treatments in the weeks to follow while Delta remained a prevalent, albeit diminishing, variant. The potential for a positive outcome in the small percentage of Delta patients was a calculated trade-off to potentially giving an Omicron patient ineffective treatment, a senior official said. The vast majority of coronavirus cases are not sequenced to determine the variant, and doctors often make treatment decisions without knowing which strand of the virus the patient is infected with.

But with Delta now accounting for a very small share of cases in most regions, the Biden administration had hoped most states would have moved away from the monoclonal antibody treatments, a senior official said.

There are also concerns widespread use of the treatments could put people at unnecessary risk for the adverse effects from receiving monoclonal antibodies. According to the National Institutes of Health, some patients have reported rashes, diarrhea, nausea and dizziness after treatment. A small percentage of patients had severe allergic reactions.

The Biden administration has pushed for states to pivot to other treatments that have demonstrated greater effectiveness against the Omicron variant, including the Merck and Pfizer antiviral pills, GlaxoSmithKline’s monoclonal antibody, AstraZeneca’s pre-exposure prophylaxis, and commercially available remdesivir.

On Friday, the US Food and Drug Administration expanded the use of the antiviral remdesivir for treatment of mild to moderate Covid-19 to children and people who aren’t hospitalized.

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CNN Health’s Katherine Dillinger contributed to this report.

CNN

Comments

26 Comments

  1. The vaccine doesn’t work on Omicron and they keep pushing that….let doctors and patients figure out what is the best choice to battle illness, not unelected politically motivated hacks.

          1. Such as the fact that Wikipedia is not a verifiable, reliable source of information? Why do you use it as a source when their own governing board states they are not verifiable?

                1. “That is not to say that you will not find valuable and accurate information in Wikipedia; much of the time you will. However, Wikipedia cannot guarantee the validity of the information found here. The content of any given article may recently have been changed, vandalized or altered by someone whose opinion does not correspond with the state of knowledge in the relevant fields. Note that most other encyclopedias and reference works also have disclaimers.”
                  Millions use it every day, and very, very rarely get “burned.” It is of value. But those who dismiss all of CNN’s content (largely factual, accurate) and write off many sources of info that don’t agree with their own agendas… well, they are who they are.

    1. No. We need a central regulatory body based solely on evidence and science. Doctors are willing to prescribe horse dewormer to humans and write up fraudulent vaccination exemptions.

      1. Why would you tell such a lie? Why would KTVZ allow such falsehoods? Drs that prescribe ivermectin are not prescribing horse dewormer. They are using a proven therapeutic that is being used in over 100 countries as a treatment against COVID. This is a false narrative and has been debunked many times. How nice for someone living in Bend, OR, which has the highest infection rate in the state to espouse such lies! BTW- its not Deschutes County, its not Crook County, or Prineville or Redmond. Its the City of Bend that has the highest infection rate! Must be all the hot air you liberal elitists are blowing around!

        1. The FDA has not approved its use for COVID-19. That is a fact. You have every right to criticize them for not doing so, cite the studies (there are conflicting studies) that support its use, point to what other countries have done. It’s still not refuting that fact, which is not a falsehood.

          1. Since when have doctors needed approval from the FDA to prescribe off label. They’ve been prescribing off label for many years for many ailments. Why do we listen to the FDA anyway. The same department that approves the harmful chemicals in our food also approves the chemicals to treat the effects of the former chemicals. Notice how they don’t evaluate anything naturopathic?

          2. All you say is true except The poster is calling it a horse dewormer. That is a flat out falsehood. It is an approved drug for human consumption! That is the lie you promote! That a drug approved for human consumption is a horse dewormer! Every single prescription issued in the USA is for a drug approved for Humans not Animals! Yet you support a lie!

      2. You seem completely ignorant of Ivermectin. There are human doses approved for use- and the FDA in the USA continues to research it’s effectiveness… You sound like someone who might mix rubbing alcohol into your pineapple juice- please don’t !

  2. Time to leave medicine alone. No more politics. Let doctors decide what is best for their patients. I have a reason to say this. Our dear governor delayed my right to be prescribed hydrochloriquine in 2020 for on label use of arthritis, because of her actions. Which led to a 6 month fight to get it approved by insurance and then the state for dispensing. Permanent rotation of bones happened during that time frame. Unable to repair the damage done. LEAVE POLITICS OUT OF MEDICINE.

  3. The variant of concern in Oregon- at least according to the OHA- remains the Delta… check the website- the Oh-My-Con is a mere blip on the radar- of little to no concern. Not sure what all the hysterics are about… the micron is milder than the delta- which has been declared a mild virus… who’s promoting all this misinformation anyway ?

  4. From counterpunch.org/2022/01/21/roaming-charges-40/

    + Switzerland is now reporting deaths by vaccination and booster status. Compared to unvaccinated people, the COVID mortality rate is: 9 times lower after full vaccination and 48 times lower after a booster.

    + The share of the population having received a booster shot stands at 60% in Chile, 52% in the UK, 47% in Israel, 42% in Germany, 41% in South Korea, 38% in Italy, 37% in France, 32% in Turkey and Spain, 26% in Canada, 24% in Malaysia, and …. 23% in the US.

    Let’s remember this important statistic: The U.S. with 5% of the world’s population has sustained 25% of the world’s Covid-19 deaths.

    Please: consider vaccination; it can offer protection from the agony of hospitalization and the tragedy of unnecessary death. Don’t be gas lit by disinformation.

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