Eli Lilly applies for emergency use of antibody drug for COVID-19


Or Masuko. Company ally Lily as requested the emergency use authorization of its antibody based treatment for people with mild to moderate symptoms. Of Corona Virus, the treatment is similar to the one that president trump received and they could have one hundred thousand doses ready this month and one million by the end of the year. Peter Loftus Healthcare reporter at the Wall Street Journal joins us for more or Masuko company ally. Lilley has requested the emergency use authorization of an experimental antibody based treatment that they have cove in nineteen. This is similar to what the president was getting his monoclonal antibodies. He got it from a company called regeneration but ally Lilley has something similar and they're saying that there's a works. Okay. In clinical trials it they've been going through already and they think that they can seek approval as early as next month Peter. Tell us a little bit more about this one. Well. Yes. It is a similar approach to what I think. A lot of people have heard in the news about one of the treatments that president trump got an antibody based treatment. In this case with Eli Lilly what they did was they formed a partnership with another company where they actually took a blood sample from one of the first people in the US to recover from covid nineteen and they isolated. Certain antibodies in the blood sample. These are things produced by the immune system that help someone overcome a virus and infection, and so then to make a drug out of that, you essentially clothed that antibody and make bigger quantities of it and then fuse it and people tested, and so that's what he Li- Lilley has done. They've spent the last several months manufacturing doses of this and testing them in various studies, and so what they're seeking authorization for is to use this antibody based drug as a treatment for people who are recently diagnosed covid and have mild moderate disease and with the hope that the antibody would actually prevent that disease from getting worse and keep people out of the hospital and. So he really has some results from the study so far that suggests that this antibody can do that. It's so interesting kind of getting this education as we go through this pandemic, how a lot of these therapeutics and treatments are being made an early on we were talking about convalescent plasma literally taking the blood has antibodies from people that have had covert and recovered and putting that into people. Now, we're going through these treatments. As he said, we're using those same antibodies, making clones of them and making these treatments from that. So it really is interesting how these things are developing. Tell us about the study they started it in nursing homes and tell us how will work and the effectiveness of it. I, first he for this drug was actually in hospitalized patients and that was a very small study and they haven't set a ton about that study but I think they had what they considered promising results and then they moved on to bigger study. Don, hospitalized patient. So these would be people who have a diagnosis maybe have some symptoms, but they haven't yet gone to a severe stage. So they've tested you know having those people come into the clinic and giving them the infusion and then seeing how they do the nursing home aspect of it is from yet another study where they're actually bringing the antibody. Outta various nursing homes if that nursing has or looks like it's going to have an outbreak say if there's one case of cove. What they then do is they test the antibody and other residents and staff in the nursing home either to treat any existing disease that they may have gotten from this emerging outbreak or even for its potential to prevent disease that's called the prophylactic use of the antibodies to use it as a preventive measure, not only to treat an existing infection. Lily as I said earlier, they're hoping they can get this emergency use authorization or at least try to go for in November but they're saying that they could already have a thousand doses ready this month and as many as one million by the end of the year. So if they get that authorization, they're ready to go right away. It's very similar to like the vaccine candidates that were going through their producing the doses and having them ready just in case they get approved. Then just to clarify ally really has already filed for. An emergency use authorization with the FDA, and so it's possible that decision could come relatively soon and that would be for a single antibody. The main one that I've been talking about to treat these mild to moderate cases. In addition to that, they've contesting that one antibody they've been adding the antibody, and so it's a two drug combination and that's the one that they are expecting to apply for in November. But in either case, you're right they aren't making. The doses and they have certain targets for what they can produce by the end of the year and what they've produced already it is likely that you know if they were to get a government authorization relatively soon, there would be I think an imbalance in supply and demand there would be a greater demand then doses available, and so I think there's GonNa be some work to do to figure out if there's certain types of patients that should be prioritized. For Instance Lilley said today that it's possible that you could maybe reserve this initial supply of doses maybe reserved him for people who are sixty five and older or who are overweight because those groups that seem like they are probably most at risk of worsening to severe disease. If there's not this treatment that prevents that but you know if approved is could fill this gap until the vaccines do get authorized and push through as well. So just interesting stuff and hopefully they can work it out and hopefully it's safe and

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