番茄社区

In this video, Jeremy Faust, MD, editor-in-chief of 番茄社区, looks at the rise and fall of monoclonal antibodies for COVID-19, and discusses the population most affected by the FDA's reversal of emergency use authorizations.

The following is a transcript of his remarks:

Hello, it's Jeremy Faust, editor-in-chief of 番茄社区. Thanks for joining us.

Today, I'm going to cover an article I wrote in Inside Medicine called, "."

Six monoclonal antibodies that are specifically for COVID-19, and another monoclonal antibody that we already had on hand for other reasons, were authorized for emergency use by the FDA during the pandemic.

I just want to show this chart that shows the timeline because it's very important to recognize that in 2020 we got two [monoclonal antibodies] that looked like they were promising. Then in 2021, there were four more added, of which tocilizumab [Actemra] -- the IL-6 (interleukin-6) modulator -- was one that we already had in existence, but there was high-quality data showing that it helped patients. Then in 2022, just one came on.

But the important and very unfortunate thing here to watch is to realize that with the oncoming new variants, each of these monoclonals lost its activity. It lost its effectiveness against the variant, unlike the vaccines, which have done really well in holding up, but these monoclonals have not. So one by one, they have gone off of the market, their emergency use authorization revoked in time as they became thought to have no more use.

To the point now where we actually really lost our last COVID-19-specific monoclonal antibody, which was Evusheld [tixagevimab/cilgavimab], actually two monoclonals packaged together. Evusheld was probably the one you needed to remember because it was the only one that really was being focused on outpatient use -- prophylaxis -- for immune-compromised people.

All that we have left in terms of all of these monoclonal antibodies is tocilizumab, the IL-6 receptor inhibitor. It's an inpatient medication that's really been shown to help patients who are already going to be admitted with COVID-19 to get IV IL-6 inhibitor, the tocilizumab, to decrease the bad outcomes associated with severe disease, intubation, and mortality.

So at this point, for outpatient use, we have [no monoclonal antibodies] to prevent progression to severe disease. And that's especially important when you look at people with the least protection, the immune compromised.

Here's the problem: the pipeline has dried up. Unfortunately, the thing you need to make these pipelines continue to flow is money, because the pharmaceutical companies know that they can make something that will work against the newest variant. They know that. The problem is with the variants constantly mutating, they're worried that just by the time they make the new monoclonal antibody, it might be obsolete. The next variant may wipe it out. And in fact, it could be that we're selecting for that. There could be some selective pressure there.

So the pharmaceutical companies need to be incentivized to know that if they make a product, they make a monoclonal that will help the immune compromised, that actually it will be paid for. That's tricky because the government right now is really running out of COVID funds. It's not 2020 or 2021 when there was a lot of money in the coffers to help pay for things. Now, a lot of our dollar has to be stretched across vaccines and things that work like Paxlovid [nirmatrelvir-ritonavir] and tests and other things we need to do to keep our response effective. But there's no money left over to say to these pharmaceutical companies, "Go ahead, make a new monoclonal, take the risk because even if it only works for a little while, we as a government or as a society will make you whole."

The science is there, but the political will is not. And I'm hoping that when we look at a graph like this, we realize that it is in our hands, especially as we move forward and COVID-19 increasingly becomes a problem that is most acutely felt by the immune compromised. Certainly that's always been the case in terms of the highest-risk group.

But going forward, as the population gains immunity from the vaccine, from infection, from a combination, the risk of severe disease and mortality goes down in most groups, but for the very immunocompromised, those who really have very little to fight with, this is a group of people who would benefit most [from monoclonal antibodies]. And I worry when you look at a graph like this, that we've decided for the moment to not do everything we possibly can.

For more, you can read the article at Inside Medicine, and thanks for joining us on 番茄社区.

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