‘Mission Critical’: Why the FDA Approved an Alzheimer’s Drug Update During Comms Freeze

By | January 29th, 2025

When Eisai announced in a press release this week that they’d secured FDA approval for an Alzheimer’s drug dosage change, it seemed like a break in the Trump administration’s blanket freezes placed on Health and Human Services. The FDA clarified this was “mission critical.”  

On January 25th, Eisai and Biogen announced that the FDA had approved their application for monthly maintenance dosing for the monoclonal antibody drug Leqembi. After 18 months of receiving infusions every two weeks, patients can continue receiving the drug once every four weeks. The FDA based its decision on data from Leqembi’s trials and a computer simulation modeling how changes in dosing would affect amyloid clearance and cognitive health.

Eisai’s press release announcing the FDA approval announcement took the public by surprise, not because this change to dosage was unexpected, but because of a sweeping freeze on public-facing communications issued on January 21st by the Department of Health and Human Services.

That initial HHS memo had outlined a communication ban through February 1st for all departments falling under their purview, including the National Institutes of Health and the Food and Drug Administration. This freeze restricted meetings, conferences, work travel, and external communications, ranging from official updates, to newsletters, to social media posts.

Accordingly, laboratories have been reportedly unable to buy supplies, from feed for laboratory animals to liquid nitrogen for biological sample storage. Committees set to deliberate funding for research and grants, even those scheduled beyond February 1st, were canceled abruptly, prompting outcry from scientists who say this delay risks setting back research — including some drug trials for Alzheimer’s, cancer, and other diseases — by at least six months.

However, with the announcement of Leqembi’s dosage change approval, FDA drug regulation decisions appear to be proceeding unaffected. 

“Regulatory actions, including actions on drug applications, will continue as normal,” an FDA spokesperson wrote to Being Patient. “HHS has issued a pause on mass communications and public appearances that are not directly related to emergencies or critical to preserving health. This is a short pause to allow the new team to set up a process for […] review and prioritization. There are exceptions for announcements that HHS divisions believe are mission critical, but they will be made on a case-by-case basis.”

Similar developments at the NIH

This “mission critical” language echoes the memo that has circulated at the NIH this week, sent by new acting director and NIH flu vaccine researcher Dr. Matthew Memoli, per reporting in Science magazine, STAT News, and others. The memo specified that the widespread stoppages of work at the NIH across meetings, work travel, purchases, publications, and the external sharing of information is just “a short pause to allow the new team to set up a process for review and prioritization.” 

Memoli’s memo also reportedly clarified that despite the communications freeze, communications deemed “mission critical” will continue. Mission critical announcements at the NIH at this point seem to include patient care and trials at NIH’s Clinical Center, along with any purchases involving “anything directly related to human safety, human or animal healthcare, security, biosafety, biosecurity, or IT security.” 

“Clinical trials at NIH or NIH-funded institutions are ongoing,” Memoli reportedly wrote in the memo. “Research participants can continue to participate in clinical trials at the NIH Clinical Center and at NIH-funded facilities.”

What Leqembi’s dosage update means for patients

Suzanne Schindler, a neurologist at the Washington University School of Medicine in St. Louis, told Being Patient, that with Leqembi receiving full approval in July 2023, there are now some patients who have been taking the drug for 18 months. 

“Deciding what to do at 18 months has been a major question for us,” she said. “Receiving infusions every two weeks is a major burden on patients and their families and we also have been running out of infusion capacity.”

Though she isn’t sure why the approval was prioritized, she said that she’s glad that it happened. 

While the Leqembi announcement has been shared by the drugmakers, it has not been published to the FDA’s website, presumably in light of the comms freeze.

What’s next for the U.S. government’s drug research, trials, and approvals?

The FDA is set to decide on a number of other drug applications this week. If these approval or denial announcements are considered “mission critical” by HHS, news should be announced even before the temporary comms ban is scheduled to be lifted on Feb. 1. Meanwhile, Robert F. Kennedy Jr.’s confirmation hearings for his appointment as the Health and Human Services secretary are underway.

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2 thoughts on “‘Mission Critical’: Why the FDA Approved an Alzheimer’s Drug Update During Comms Freeze

  1. I have a family member on Leqembi infusions for treatment of early onset Alzheimer’s. She is doing very well and I hope that support continues as it should!

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