The FDA is restricting the use of 2 drugs first authorized to treat COVID（在线收听）

The FDA is restricting the use of 2 drugs first authorized to treat COVID

Transcript

The FDA curbed the use of two out of three monoclonal antibody treatments. Studies show they're highly unlikely to work against the omicron variant, which is overwhelming hospitals.

STEVE INSKEEP, HOST:

Hospitals in much of this country are under extreme stress. They're caring for more COVID patients than in any other time in the pandemic. And we have news today of one reason why so many people are in the hospital. Medicine that can keep high-risk COVID patients out of hospitals is in short supply. Also, this week the FDA announced it's restricting the use of two of the first drugs authorized to treat COVID. NPR's Pien Huang joins us now. Good morning.

PIEN HUANG, BYLINE: Good morning, Steve.

INSKEEP: Why is the FDA restricting two COVID drugs?

HUANG: Well, so on Monday, the FDA curbed the use of two out of three monoclonal antibody treatments. And these two drugs, made by Regeneron and Eli Lilly, worked well earlier in the pandemic. But recent lab studies show that they're highly unlikely to work against the omicron variant. And remember, omicron now accounts for around 99% of U.S. cases.

INSKEEP: Yeah.

HUANG: Erin Fox, a pharmacy director at University of Utah Health, says the FDA is following the science.

ERIN FOX: Honestly, I'm shocked that it took them this long to do it because things are bad enough without wasting valuable health care provider time infusing a medicine that is not going to be effective.

HUANG: Omicron has dominated since Christmas, but every state has continued to get these two treatments. Now the Department of Health and Human Services, which distributes these drugs, has stopped sending them out.

INSKEEP: I can feel the politics coming into this because people who have stressed vaccine choice, choice to avoid vaccines, have instead stressed treatments like the monoclonal antibodies. And you're telling me that some of them have now been disallowed. What are some state officials saying about this?

HUANG: Well, as you mentioned, state officials are not necessarily happy about this in some states. The FDA's move prompted Florida's health department to shut down all of its state-run antibody treatment sites. Governor Ron DeSantis called for the Biden administration to reverse this decision - accused the president of, quote-unquote, "medical authoritarianism." But even the makers of the drugs acknowledge that they don't work well against omicron.

Now, there is one antibody drug left called sotrovimab that does work against omicron, but it's in very short supply. Each week, there are only around 50,000 doses available for the whole country, and that's not nearly enough to go around.

INSKEEP: Hasn't the FDA recently expanded the use of another drug, though?

HUANG: That's right. So the drug is called remdesivir. It was the first antiviral drug to get FDA approval back in 2020. But at the time, it was only for very sick patients in the hospital. Now, recently, the FDA broadened that approval to include patients not sick enough to be hospitalized. Dr. Raymund Razonable at Mayo Clinic in Minnesota says recent research shows that for high-risk patients, remdesivir reduced the risk of getting hospitalized by 87%.

RAYMUND RAZONABLE: And it confirms what people - what I, as an infectious disease provider - have assumed from the very beginning, that for antivirals to work, it has to be given early.

HUANG: Now, Razonable calls it a blessing that the evidence for remdesivir came out right as omicron was coming in. And there's plenty of this drug available, but it's also not very easy to administer. A patient has to go to a clinic and get IV infusions over three consecutive days.

INSKEEP: Which sounds like a lot. Aren't there pills you could take at home?

HUANG: Yeah, there are two pills - Paxlovid from Pfizer and molnupiravir from Merck. And out of these two pills, doctors are more inclined to prescribe Paxlovid. It works twice as well as molnupiravir in keeping patients out of the hospital. But these pills are also not easy to get. For the past two weeks, 500,000 courses of both drugs went out at a time when 10 million people tested positive. Carl Dieffenbach with NIH says the situation with treatments is starting to get better.

CARL DIEFFENBACH: So as the omicron surge wanes, demand will go down. At the same time, supply is going up.

HUANG: Dieffenbach says that drug companies are also whipping up new monoclonal antibodies, which could be available soon.

INSKEEP: NPR health reporter Pien Huang, thanks so much.

HUANG: Thanks for having me.