F.D.A. Grants Emergency Authorization of Antibody Treatment Given to Trump

[BumRushDaShow]

Source: New York Times

The Food and Drug Administration has granted emergency authorization for the experimental antibody treatment given to President Trump shortly after he was diagnosed with Covid-19, giving doctors another option to treat Covid-19 patients as cases across the country continue to rise.

The treatment, made by the biotech company Regeneron, is a cocktail of two powerful antibodies that have shown promise in early studies at keeping the infection in check, reducing medical visits in patients who get the drug early in the course of their disease. A similar treatment, made by Eli Lilly, was given emergency approval earlier this month.

The emergency authorization for Regeneron’s drug is limited in scope: It is for people who have tested positive for the coronavirus and who are at high risk for developing severe Covid-19. Evidence so far suggests that antibody treatments work best early in the course of the disease, before the virus has gained a foothold in the body. Like Eli Lilly’s treatment, Regeneron’s is not authorized for use in people who are hospitalized or who need oxygen.

The emergency authorization raises immediate questions about who will get access to the treatments as an average of more than 168,000 people are diagnosed each day with Covid-19 in the United States and hospitals are running out of beds in some regions of the country. Regeneron has said it will have enough of the drug for only about 80,000 people by the end of November, enough for 200,000 patients by the first week of January, and 300,000 by the end of January. After that, the company said it will be able to ramp up production thanks to a partnership with the Swiss manufacturer Roche.

Read more: https://www.nytimes.com/2020/11/21/health/regeneron-covid-antibodies-trump.html

[soothsayer]

1. This is what Ben Carson took ahead of this authorization?

[SunSeeker]

8. Yepper pepper. It's good to have friends in high places.

The rest of us are on our own.

[RandySF]

2. I believe Trump received this when he was infected.

[SunSeeker]

7. Yep, right away. The Regeneron CEO is his golf buddy.

https://www.forbes.com/sites/roberthart/2020/10/08/while-trump-touts-cure-made-by-regeneron-its-ceo-is-a-member-of-trump-golf-club/amp/

[captain queeg]

3. Now it'll be easier to give to junior?

[BumRushDaShow]

4. Probably the only ones who could afford it

I think I read that it was some obscene price per treatment.

[Newest Reality]

5. I think availability will be.

I think availability will be the issue more than price. It is estimated that Regeneron will cost between $1,200 to $1,500 a dose.

So, who gets it when the supply is limited is the main factor. Jr. probably will.

[BumRushDaShow]

6. Because it is such a unique and targeted drug/biologic

the availability would always be a given and an issue (and I expect the patent was already filed some time ago, so no "generics" any time soon, although you often have companies already working on one anyway ).

[mpcamb]

9. US government bought 300,000 doses each at a cost of about $1,250/$1,500 per dose

"...the government has bought 300,000 doses each from Lilly and Regeneron at a cost of about $1,250 and $1,500 p, respectively, with an option to buy hundreds of thousands more."
WaPo article
https://www.washingtonpost.com/health/2020/11/21/regeneron-fda-clearance/