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Is The FDA Still Approving Drugs During the Pandemic?

By Brian Orelli, PhD - Dec 4, 2020 at 11:06AM

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Multiple drugmakers gained FDA approval last week.

Despite delays due to travel restrictions for inspections by the Food and Drug administration, the agency is still approving drugs unrelated to the COVID-19 pandemic after virtual review of manufacturing documents.

In this video from Motley Fool Live recorded on Nov. 30, Healthcare and Cannabis Bureau Chief Corinne Cardina and Fool.com contributor Brian Orelli discuss the authorizations of Alnylam Pharmaceuticals' ( ALNY 1.50% ) Oxlumo and Regeneron Pharmaceuticals' ( REGN 1.45% ) COVID-19 antibody cocktail components casirivimab and imdevimab.

Corinne Cardina: Despite all these issues with FDA inspections, the agency did make a few decisions. They approved or authorized a few drugs in the past couple of weeks that I'd love to get your take on. The first one is from Alnylam Pharmaceuticals. On Nov. 23, it won FDA approval for its third medicine. It's an injection called off Oxlumo that it's used to treat a rare genetic disorder. It's the first approved treatment for patients with a potentially life-threatening condition that can cause kidney failure. Like Alnylam's other drugs, it comes at a six-figure list price. Brian, how does a company like this actually make its money? Who can afford more than $100,000 for their medication? Is this insurers and government payers splitting that big of a bill?

Brian Orelli: The disease here is primary hyperoxaluria type 1, it's too much oxalate in the patients. That's what causes the kidney and liver problems. The reason why they can charge that much is they're also saving insurers or government, those people who are actually paying for it, a lot of money because their patients don't have to go on dialysis and eventually, patients will have liver and kidney transplant. Those cost hundreds and hundreds of thousands of dollars. It's also a small number of patients, so the insurers don't really hit that hard. There's like 1,000-1,700 patients in Europe and the US combined.

I'm always convinced that the companies just take the market potential and use that number and divide one billion by it, and that's how they come up with a price tag. You can take 1,000 patients and you charge $100,000, that's basically a billion dollars. I think companies are always trying to get on the blockbuster list. Sometimes I feel like that's how they come up with the price. Drugs like Lipitor which treat a whole bunch of different people can charge a heck a lot less than a drug like this where they're only treating 1,000-1,700 patients.

Corinne Cardina: Yeah, I think you're absolutely right about that. Another decision the FDA made was for Regeneron Pharmaceuticals, their COVID-19 antibody cocktail was cleared for an emergency use authorization. Its partner for manufacturing this is Roche. A couple weeks earlier, Eli Lilly ( LLY -1.71% ) got the same clearance for a similar antibody cocktail. What are your thoughts on the potential for antibody cocktails for COVID-19?

Brian Orelli: The literal weight of the antibodies, we need quite a bit of it. That affects both the manufacturing issues, both for cost of goods as well as capacity. That's a big issue with the antibody cocktails. Then you need to use them early, but there's also a mandate to only use them on the most vulnerable patients. I think that's really difficult and challenging for doctors because they have to try to guess who's most likely to progress. I think that's difficult.

Corinne Cardina: If there's one thing we know, it's that COVID-19 is unpredictable, so these hard and fast rules can be hard to nail down.

This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis – even one of our own – helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.

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Stocks Mentioned

Alnylam Pharmaceuticals, Inc. Stock Quote
Alnylam Pharmaceuticals, Inc.
ALNY
$179.66 (1.50%) $2.66
Eli Lilly and Company Stock Quote
Eli Lilly and Company
LLY
$242.12 (-1.71%) $-4.21
Regeneron Pharmaceuticals, Inc. Stock Quote
Regeneron Pharmaceuticals, Inc.
REGN
$634.08 (1.45%) $9.08

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