FDA to hold meeting for Alzheimer’s drug in June, Texas judge makes ruling on abortion pill
Yahoo Finance health care reporter Anjalee Khemlani joins the Live show to discuss an upcoming FDA meeting on the Alzheimer's drug Leqembi and a ruling by a U.S. District Court judge in Texas on the abortion pill mifepristone.
影片文字轉錄稿
SEANA SMITH: All right, well, after fast-tracking Eisai and Biogen's Alzheimer's drug Leqembi in January, the FDA will be convening a panel of outside experts in June to discuss full approval. Yahoo Finance's Anjalee Khemlani joins us now with more. And Anj, what does the timeline look like for this? And how significant could this be?
ANJALEE KHEMLANI: Well, this is significant for the company because it broadens the potential customer base that the company has. Right now they have that fast-track approval, which gives them the ability to market the drug and whoever is willing to pay cash.
And so what we're looking at now is the June meeting of the outside panel of experts and then the FDA'S final decision. It looks pretty promising based on the company's expectations. We had spoken to Eisai US chairman and CEO earlier, Ivan Cheung. And here's what he had to say about that.
IVAN CHEUNG: Saying that on the same day of Leqembi receiving a full traditional approval, broader access will be provided. We find that very encouraging. And we have been working very closely with the CMS, including a recent meeting after the Leqembi accelerated approval to chart the path forward.
ANJALEE KHEMLANI: So as you can hear, they already were working on this, charting a path forward. They're expecting the approval this summer. So it looks like things are already on their way.
JARED BLIKRE: All right, we got to talk Texas here for a second, the pharma industry responding to this Texas ruling on the abortion pill, kind of stirring up some controversy here. What's the latest?
ANJALEE KHEMLANI: That's right. So the drug companies are worried about the impact that this has. There are multiple reasons why the FDA could see its authority really interfered with. But the drug companies themselves are worried about the impact long-term from the industry. What if any drug, just like-- we were just talking about Eisai, their partner Biogen with those Alzheimer's drugs--
Do you remember the drama over aduhelm? So they're worrying about stuff like that that could come down the pike. They said in this letter, quote, "If courts can overturn drug approvals or evidence or for the--" sorry. "--or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk."
So it opens up the floodgates for already a very litigious situation in the industry. People already sue the companies a lot. So this would just make it one step worse. And we've seen some really big wigs sign on just today, Pfizer among them, Biogen among them, as well as CRISPR and Merck. So really interesting lineup right there.
SEANA SMITH: And certainly a story, I'm sure, that we are going to continue tracking. Anj, thanks so much.