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Healthcare

Merck to seek emergency authorization for pill it says cuts COVID-19 effects

A MARTINEZ, HOST:

Positive results this morning from a study of a new drug to treat COVID-19 - according to a news release from the drug company Merck, the drug cut hospitalization or death in half for people sick with COVID.

Joining us now to talk about the new results is NPR's Joe Palca. Joe, tell us about this new drug.

JOE PALCA, BYLINE: Well, it's an antiviral drug called molnupiravir. And it's different from monoclonal antibody therapy because it works by blocking the ability of the virus to replicate, in the same way some of the AIDS drugs block the replication of HIV. It was developed a number of years ago by researchers at Emory University.

MARTINEZ: I've got to say, the study results - reducing death or hospitalization by half - that sounds pretty impressive.

PALCA: Yes, it really does. And here's what former FDA commissioner Scott Gottlieb had to say about it this morning on CNBC.

(SOUNDBITE OF ARCHIVED RECORDING)

SCOTT GOTTLIEB: This is a phenomenal result. I mean, this is a profound game changer, to have an oral pill that had this kind of effect, this magnitude of effect in patients who are at high risk who are already symptomatic.

PALCA: Now, the results haven't been published yet. So as you said when we started, this is all coming from a company news release. But here's what we know from the company. It was tested in 775 people who had mild-to-moderate COVID-19. Treatment started within five days of the appearance of symptoms. And also, all the people in the study were at risk of severe disease because of some underlying health problem.

Half got the drug. Half got the placebo. And 7% of the patients receiving the drug were either hospitalized or died, compared with 14% percent who received placebo. So as you say, that's cutting the rate in half. But for perspective, you could turn that on its head and say, well, 86% of the people getting the placebo didn't wind up being hospitalized or dying, compared with 93% who didn't if they took the drug. So - and another thing to keep in mind is monoclonal antibody therapy, which is already out there, works a little bit better.

MARTINEZ: Yeah.

PALCA: But it's harder to administer. And the pill is much easier - obviously, an oral pill. And it's much easier to make than the monoclonal antibodies.

MARTINEZ: Any serious side effects reported?

PALCA: No. There were none from this study - that they report, anyway. But there have been reports from laboratory tests that this drug could cause genetic mutations. And it was interesting that the men in this study were urged to refrain from sexual intercourse while they were taking the drug...

MARTINEZ: OK.

PALCA: ...Because they didn't want people to get pregnant.

MARTINEZ: So what happens next?

PALCA: Well, Merck says it will apply to the Food and Drug Administration for what's called an emergency use authorization. That's not approval. But, you know, these have been used as a way of getting things available much faster. And the company says that it has 1.7 million courses of therapy ready to go if and when the drug is authorized.

MARTINEZ: One more thing - any more drugs like this in the pipeline?

PALCA: Yeah. There are a couple. Both the giant companies Roche and Pfizer say they've got similar drugs in the pipeline. So we may be hearing more about this before too terribly long.

MARTINEZ: All right. That's NPR's Joe Palca. Joe, thanks a lot.

PALCA: You're welcome. Transcript provided by NPR, Copyright NPR.

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