US approves Regeneron antibody treatment given to Trump

[aum]

A COVID-19 antibody therapy used to treat President Donald Trump was approved by the US drug regulator on Saturday for people who aren't yet hospitalized by the disease but are at high risk.

 

The green light for drugmaker Regeneron came after REGEN-COV2, a combination of two lab-made antibodies, was shown to reduce COVID-19-related hospitalizations or emergency room visits in patients with underlying conditions.

 

"Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system," said Stephen Hahn, commissioner of the Food and Drug Administration (FDA).

 

Leonard Schleifer, Regeneron's president and CEO, added the move was "an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection."

 

Regeneron's antibody treatment is the second synthetic antibody treatment to receive an emergency use approval (EUA) from the FDA after a similar therapy developed by Eli Lilly was granted the status on November 9.

 

The human immune system naturally develops infection-fighting proteins called antibodies—but because not everyone mounts an adequate response, companies like Regeneron and Lilly have manufactured lab-made solutions.

 

They work by binding to a surface protein of the SARS-CoV-2 virus and stopping it from invading human cells.

 

The FDA said the data supporting Regeneron's EUA came from a clinical trial in 799 non-hospitalized patients with mild to moderate symptoms of COVID-19.

 

For patients who were at high risk because of a variety of underlying conditions—from obesity to old age to diabetes—hospitalization and emergency room visits occurred in three percent of patients who received the intravenous treatment.

 

This compared to nine percent in placebo-treated patients.

 

Patients treated with the drug also had lower levels of virus remaining compared to those on the placebo.

 

80,000 doses

 

The company said it expects to have doses ready for 80,000 patients ready by the end of November and approximately 300,000 patients in total by the end of January 2021.

 

These will be available to US patients at no out-of-pocket cost under the terms of a US government program.

 

But with cases surging across the US and globally, that means access will not be widespread. The US has added more than 360,000 new COVID-19 cases in the past two days alone.

 

The recommended dose is 1,200 milligrams of each of the two antibodies, for a total of 2,400 milligrams, in a single infusion.

 

Regeneron has received more than $450 million from the US government for its COVID-19 drug development efforts under Operation Warp Speed.

 

So-called monoclonal antibodies are a relatively new class of drug seen as highly promising.

 

Last month, an antibody drug developed by Regeneron against the Ebola virus received full FDA approval, the next step after an EUA.

 

In the case of COVID-19, Regeneron first found two antibodies that were highly effective against the SARS-CoV-2 virus, one from a mouse whose immune system was modified to be human-like, the other from a human.

 

They then harvested the immune cells that made those antibodies and grew them in a lab, in order to create a mass treatment.

 

COVID-19 vaccines, like those developed by Pfizer and Moderna, work by training the immune system to make its own antibodies so they are prepared when they encounter the virus.

 

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[steven36]

Regeneron Antibody Cocktail For Covid-19 Coronavirus Gets FDA Emergency Use Authorization

 

Hip, hip, EUA.

 

 

That could be Regeneron Pharmaceuticals’ reaction to Saturday’s news about their product REGEN-CoV2, the antibody cocktail that U.S. President Donald Trump received at Walter Reed Medical Center when he recently had Covid-19. This combination of casirivimab and imdevimab has now received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to treat mild to moderate Covid-19. In order to receive the treatment, patients should be at least 12 years old and 40 kg in weight. Forty kilograms is about 88 pounds or four-fifths the weight of an octopus just in case you are wondering.

 

Casirivimab and imdevimab may seem like great words for Scrabble when you’re stuck with a bunch of “v’s” and “i’s” and want to use something besides the Coldplay song title "Viva la Vida." But they are also the names of recombinant human IgG1 monoclonal antibodies. The word “recombinant” comes from “recombine,” as in recombining genetic material in different ways in the laboratory to produce new types of antibodies. Antibodies are proteins that can bind and potentially neutralize specific proteins such as those that are part of an invading virus.

 

In this case, the proteins that casirivimab and imdevimab target are the spikes on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus looks like a very, very small spiky massage ball but is not the same. If someone tries to massage you with the Covid-19 coronavirus, leave the spa immediately. The spikes on the SARS-CoV2 aren’t supposed to make you feel good.

 

Instead they are naughty spikes, helping the virus get into your cells to infect them, sort of like when you use a crow bar to get into a locked cabinet that has something valuable like toilet paper rolls in it. So antibodies binding these spikes may be able to then keep the SARS-CoV2 from getting into your cells.

 

REGEN-CoV2 is the second antibody therapy for Covid-19 to receive an EUA from the FDA. Earlier this month, the FDA granted Eli Lilly and Company an EUA for bamlanivimab. Like the components of REGEN-CoV2, bamlanivimab is not easy to pronounce and targets the spike protein of SARS-CoV-2 as well.

 

Keep in mind that neither REGEN-CoV2 nor bamlanivimab is a “cure” for Covid-19, Despite Trump calling REGEN-CoV2 a cure after he received the treatment at Walter Reed Medical Center, as Jack Brewster reported for Forbes, there is currently no cure for Covid-19. Calling anything a cure right now would be a premature declaration.

 

What REGEN-CoV2 may do is reduce your risk of progressing to more severe Covid-19 when you already have mild-to-moderate Covid-19. A study published in the journal Science showed that REGN-CoV2 was able to greatly reduce the amount of virus in the lower and upper airways and decrease the damage caused by the virus in rhesus macaques infected with SARS-CoV2. This was good rhesus pieces of evidence that the treatment may work in humans. The study also showed that the treatment could decrease weight loss, the amount of virus in the lungs, and evidence of pneumonia in hamsters infected with the SARS-CoV2. Of course, what happens in a rhesus macaque or a hamster may not necessarily apply to you, unless you happen to be a gigantic hamster. While rhesus macaques and hamsters do have some similarities to you and other humans, they are different in many important ways as well. For example, macaques and hamsters don’t tend to take as many selfies as humans. They also may not always respond to infections and treatments exactly the same way as humans do.

 

Therefore, the FDA had to wait until enough data from human trials were available to determine whether REGN-CoV2 is safe and effective enough to use in humans. Since the Covid-19 coronavirus really only emerged in January, which was approximately 11 missed haircuts ago, there hasn’t been too much time to test the treatment in humans. Regeneron pulled together a Phase 1/2/3 trial that is ultimately going to recruit at least 1,300 patients for the Phase 2/3 portion. At the end of September, Regeneron did release some of the findings from the Phase 2/3 portion, including an analysis of the first 275 patients to receive the treatment. REGN-CoV2 seemed to reduce the viral loads and the time to symptoms resolving in patients who had Covid-19 but didn’t require hospitalization. Those who received the treatment also tended to have fewer subsequent medical visits. Such results were apparently enough to earn the EUA from the FDA.

 

Remember a EUA doesn’t mean that the treatment has been fully approved as a treatment. It doesn’t mean that you will soon be seeing REGEN-CoV2 television commercials of people dancing in grassy fields in slow motion. It means that during an emergency, which is what the Covid-19 coronavirus pandemic is, the FDA has determined that in certain situations the potential benefits of administering casirivimab and imdevimab may outweigh the possible risks.

 

Again it’s important to remember that REGEN-CoV2 is not a cure for Covid-19. It is something that could potentially, possibly in some cases reduce the chances of mild-to-moderate Covid-19 progressing to more severe disease. The EUA doesn’t mean that you can begin foregoing social distancing, face mask use, and other Covid-19 coronavirus prevention measures. It doesn’t mean that you can start playing Twister with people outside your social bubble or form a choir to sing Sia’s song “Chandelier” together. Don’t begin taking risks and rely on the REGEN-CoV2 to rescue you in case you get infected with the SARS-CoV2. It’s simply not that kind of treatment.

 

REGEN-CoV2 will be in short supply anyway. Monoclonal antibodies don’t exactly grow on trees and will take time to manufacturer. As the following tweet indicated, you may not even have access to the treatment.

 

Moreover, REGEN-CoV2 may not be the most affordable therapy. A CBS News report from Stephen Gandel estimated that REGEN-CoV2 could cost somewhere between $1,500 and $6,500 per treatment. That’s potentially over 220 to 950 pieces of avocado toast to put things in perspective, depending on whether goat cheese is involved.

 

Trump may have gotten the therapy for free, but you are not Donald Trump, unless, of course, you happen to be Donald Trump. You aren’t on the same government insurance plan that Trump is on to pay for REGEN-CoV2. Sure, Trump has claimed that he will make REGEN-CoV2 “free” for all Americans. But take such claims with a golf bag full of salt. Trump may not follow through on that promise, especially since he is a lame duck President. Therefore, don’t bank on the therapy being free until you actually see it happen.

 

Nevertheless, this EUA does add another possible therapy for mild-to-moderate Covid-19. And it’s not as if doctors are saying, there are just too many different ways to treat Covid-19 right now. In fact, it’s quite the opposite, with doctors still struggling to find ways to deal with the consequences of the infection. With the Covid-19 coronavirus surging in the U.S. and the national pandemic response currently being about as organized as a ballroom dance competition run by hedgehogs, doctors will need all the treatment options that they can get.

 

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