WEBVTT - Eli Lilly Seeks Emergency Use Authorization for Its COVID-19 Antibody Treatment

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<v Speaker 1>It's Thursday, October eight. I'm Oscar Ramirez from the Daily

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<v Speaker 1>Dive podcast in Los Angeles, and this is reopening America.

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<v Speaker 1>More good news on treatments for COVID nineteen. Pharmaceutical company

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<v Speaker 1>Eli Lily has requested the emergency use authorization of its

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<v Speaker 1>antibody based treatment for people with mild to moderate symptoms

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<v Speaker 1>of coronavirus. The treatment is similar to the one that

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<v Speaker 1>President Trump received, and they could have one thousand doses

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<v Speaker 1>ready this month and one million by the end of

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<v Speaker 1>the year. Peter loftus healthcare reporter at the Wall Street Journal,

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<v Speaker 1>joins us for more. Pharmaceutical company Eli Lily has requested

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<v Speaker 1>the emergency use authorization of an experimental antibody based treatment

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<v Speaker 1>that they have for COVID nineteen. This is similar to

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<v Speaker 1>what the President was getting this monoclonal antibodies. He got

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<v Speaker 1>it from a company called Regeneron, but Eli Lily has

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<v Speaker 1>something similar and they're saying that there's works okay and

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<v Speaker 1>in clinical trials that they've been going through already, and

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<v Speaker 1>they think that they can seek approval as early as

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<v Speaker 1>the next month. Peter tell us a little bit more

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<v Speaker 1>about this one. Well, yes, it is a similar approach

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<v Speaker 1>to what I think a lot of people have heard

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<v Speaker 1>in the news about one of the treatments that President

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<v Speaker 1>Trump got, an antibody based treatment. In this case with

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<v Speaker 1>Eli Lially, what they did was they formed a partnership

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<v Speaker 1>with another company where they actually took a blood sample

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<v Speaker 1>from one of the first people in the US to

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<v Speaker 1>recover from COVID nineteen and they isolated certain antibodies in

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<v Speaker 1>the blood sample. These are things produced by the immune

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<v Speaker 1>system that helped someone overcome a virus and infection, and

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<v Speaker 1>so then to make a drug out of that, you

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<v Speaker 1>essentially clone that antibody and make bigger quantities of it

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<v Speaker 1>and then confuse it in people to test it. And

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<v Speaker 1>so that's what Eli Lily has done. They've spent the

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<v Speaker 1>last several months manufacturing doses of this and then testing

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<v Speaker 1>them in various studies. And so what they're seeking authorization

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<v Speaker 1>for is to use this antibody based drug as a

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<v Speaker 1>treatment for people who are recently diagnosed with COVID and

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<v Speaker 1>have mild moderate disease, and with the hopes that the

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<v Speaker 1>antibody would actually prevent that disease from getting worse and

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<v Speaker 1>keep people out of the hospital. And so ELI only

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<v Speaker 1>has some results from the studies so far that suggests

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<v Speaker 1>that this antibody can do that. It's so interesting kind

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<v Speaker 1>of getting this education as we go through this pandemic,

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<v Speaker 1>how a lot of these therapeutics and treatments are being made.

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<v Speaker 1>And early on we were talking about convalescent plasma, literally

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<v Speaker 1>taking the blood that has antibodies and it from people

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<v Speaker 1>that have had COVID and recovered and putting that into people.

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<v Speaker 1>Now we're going through these treatments. As you said, we're

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<v Speaker 1>using those same antibodies and making clones of them and

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<v Speaker 1>kind of making these treatments from that. So it really

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<v Speaker 1>is interesting how these things are developing. Tell us about

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<v Speaker 1>the study they started it in nursing homes and tell

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<v Speaker 1>us how it worked and with the effectiveness of it.

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<v Speaker 1>The first study for this drug was actually the inhospitalized patients,

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<v Speaker 1>and that was a very small study and they haven't

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<v Speaker 1>said a ton about that study, but I think they

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<v Speaker 1>had what they considered promising results, and then they moved

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<v Speaker 1>on to somewhat bigger study in non hospitalized patients. So

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<v Speaker 1>these would be people who have a diagnosis, maybe have

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<v Speaker 1>some symptoms, but they haven't yet gotten to a severe stage.

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<v Speaker 1>So they've tested, you know, having those people come into

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<v Speaker 1>a clinic and giving them the infusion and then seeing

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<v Speaker 1>how they do. The nursing home aspect of it is

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<v Speaker 1>from yet another study where they're actually bringing the antibody

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<v Speaker 1>out to various nursing homes if that nursing home has

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<v Speaker 1>or looks like it's going to have an outbreak, say

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<v Speaker 1>if there's one case of COVID. What they then do

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<v Speaker 1>is they test the antibody in other residents and staff

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<v Speaker 1>in the nursing home, either to treat any existing disease

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<v Speaker 1>that they may have gotten from this emerging outbreak, or

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<v Speaker 1>even for its potential to prevent disease. That's called the

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<v Speaker 1>prophylactic use of the ant body, is to use it

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<v Speaker 1>as a preventive measure, not only to treat an existing infection.

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<v Speaker 1>Eli Lily. As I said earlier, they're hoping they can

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<v Speaker 1>get this emergency use authorization or at least try to

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<v Speaker 1>go for it in November, but they're saying that they

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<v Speaker 1>could already have a hundred thousand doses ready this month

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<v Speaker 1>and as many as one million by the end of

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<v Speaker 1>the year. So if they get that authorization, they're ready

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<v Speaker 1>to go right away. It's very similar to like the

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<v Speaker 1>vaccine candidates that we're going through. Their producing the doses

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<v Speaker 1>and having them ready just in case they get approved.

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<v Speaker 1>And just to clarify ELI, Lily has already filed for

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<v Speaker 1>an emergency use authorization with the f d A, and

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<v Speaker 1>so it's possible that that decision could come relatively soon,

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<v Speaker 1>and that would be for the single antibody, the main

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<v Speaker 1>one that I've been talking about to treat these mild

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<v Speaker 1>to moderate cases. In addition to that they've been testing

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<v Speaker 1>that the one antibody, they've been adding a second antibody,

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<v Speaker 1>and so it's a two drug combination, and that's the

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<v Speaker 1>one they are expecting to apply for in November. But

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<v Speaker 1>in either case, you're right, they are making the doses,

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<v Speaker 1>and they have certain targets for what they can produce

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<v Speaker 1>by the end of the year, and what they've produced already,

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<v Speaker 1>it is likely that, you know, if they were to

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<v Speaker 1>get a government authorization relatively soon, there would be I

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<v Speaker 1>think an imbalance in supply and demand. There would be

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<v Speaker 1>a greater demand than doses available, and so I think

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<v Speaker 1>there's going to be some work to do to figure

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<v Speaker 1>out if there's certain types of patients that should be prioritized,

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<v Speaker 1>and for instance, literally said today that it's possible that

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<v Speaker 1>you could maybe reserved this initial supply of doses, maybe

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<v Speaker 1>reserve them for people who are sixty five and older

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<v Speaker 1>or who are overweight, because those are the groups that

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<v Speaker 1>seem like they are probably most at risk of worsening

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<v Speaker 1>to severe disease if there's not this treatment that prevents that.

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<v Speaker 1>But you know, if approved, this could kind of fill

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<v Speaker 1>this gap until the vaccines do get authorized and pushed

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<v Speaker 1>through as well. So just interesting stuff and hopefully they

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<v Speaker 1>can work it out and hopefully it's safe and effective.

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<v Speaker 1>Peter loftis healthcare reporter at the Wall Street Journal. Thank

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<v Speaker 1>you very much for joining us my pleasure. I'm Astar

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<v Speaker 1>Ramirez and this has been reopening America. Don't forget effort

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<v Speaker 1>today's big news stories. You can check me out on

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