'Subcutaneous Lecanemab Maintenance Dosing for Alzheimer's Supported by New Data'

 An investigational subcutaneous autoinjector showed comparable efficacy and safety to the IV formulation of lecanemab (Leqembi) for maintenance treatment in early Alzheimer's disease, researchers said here.

Continued lecanemab treatment with 360 mg subcutaneous dosing resulted in a similar additional reduction of amyloid PET over 4 years of treatment as continuing biweekly IV lecanemab, reported Larisa Reyderman, PhD, of drugmaker Eisai, at the Alzheimer's Association International Conferenceopens in a new tab or window (AAIC).

There were no differences in clinical outcomes including Clinical Dementia Rating-Sum of Boxes (CDR-SB) scores between continued biweekly IV doses and 360 mg subcutaneous maintenance dose regimens, Reyderman said.

Weekly dosing with the 360 mg subcutaneous formulation maintained plasma biomarkers of amyloid-beta, glial fibrillary acidic protein (GFAP), and phosphorylated tau 181 (p-tau181), she added.

"Transitioning to weekly 360 mg subcutaneous autoinjector maintenance dosing after 18 months is similar to continuing IV 10 mg/kg biweekly dose for maintaining amyloid reduction and clinical efficacy," Reyderman stated.

Subcutaneous dosing can reduce the burden for patients and caregivers while still maintaining the efficacy observed with lecanemab biweekly treatment, she added.

"Modeling indicates that maintenance therapy with subcutaneous lecanemab prevents biomarker re-accumulation and has no significant meaningful impact on amyloid or meaningful impact on disease progression compared to the intravenous regimen," she said.

Lecanemab is a monoclonal antibody with high affinity to amyloid-beta soluble protofibrils. It was approved in 2023opens in a new tab or window as an IV infusion for early symptomatic Alzheimer's disease with IV maintenance dosing also approved.

The FDA approval's was based on the phase III CLARITY ADopens in a new tab or window trial in which lecanemab reduced amyloid and slowed clinical decline on several measures of cognition and function, including CDR-SB scores at 18 months.

Lecanemab comes with a boxed warning about amyloid-related imaging abnormalitiesopens in a new tab or window (ARIA), including ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). ARIA is usually asymptomatic but can be fatal. The lecanemab label also indicates that serious intracerebral hemorrhages greater than 1 cm have occurred in patients treated with monoclonal antibodies directed against aggregated forms of beta amyloid.

At AAIC, Eisai researchers discussed whether a subcutaneous lecanemab autoinjector might be an effective maintenance treatment option after 18 months of IV therapy. Clinical trials of subcutaneous lecanemab were conducted as a substudy of the open-label extension of the CLARITY AD study.

The safety profile of 360 mg weekly subcutaneous maintenance dosing was consistent with that of IV maintenance therapy, reported Eisai's Michael Irizarry, MD. Across all subcutaneous doses tested, the rate of systemic injection or infusion reactions was 1%, compared with 26% for IV dosing.

The 360 mg subcutaneous maintenance dose was initiated after 18 months of IV treatment, beyond the typical high-risk period for ARIA. Among 49 people treated with a 360 mg subcutaneous weekly maintenance dose of lecanemab for a mean of 6 months, there were no cases of ARIA-E and one case of ARIA-H. One intracerebral hemorrhage greater than 1 cm occurred in the 360 mg subcutaneous group that was not included in the ARIA-H data. "There were no new deaths related to amyloid-related imaging abnormalities," Irizarry said.

Other studies showed that most participants (95%) successfully administered the maintenance dose and most said the autoinjector was easy to use. The FDA is expected to decideopens in a new tab or window whether to approve the lecanemab subcutaneous autoinjector by August 31.

In a separate AAIC session, Christopher van Dyck, MD, of Yale University in New Haven, Connecticut, reviewed the long-term safety and efficacy of lecanemab treatment from CLARITY AD and its open-label extension.

Over 4 years of treatment, lecanemab demonstrated a reduction in cognitive decline based on CDR-SB scores compared with the expected decline from a matched cohort from the Alzheimer's Disease Neuroimaging Initiative (ADNI)opens in a new tab or window. Similarly, lecanemab showed a reduction in cognitive decline at 4 years versus the expected decline in the Swedish BioFINDERopens in a new tab or window cohort.

Benchmarked against ADNI, 4 years of lecanemab treatment reduced the relative risk of progression to the next stage of Alzheimer's disease by 34%. In a subset of CLARITY AD participants with low tau, more than half (56%) had improvement on CDR-SB after 4 years of lecanemab therapy, van Dyck noted.

"In CLARITY AD, the observed increasing treatment difference with ongoing lecanemab treatment in participants treated through 48 months versus matched controls -- ADNI and BioFINDER -- is consistent with a disease-modifying effect," he said. The long-term safety profile of lecanemab was confirmed, with no new safety signals, he added.

The new data expanded lecanemab's 3-year findingsopens in a new tab or window that van Dyck showed at the 2025 American Academy of Neurologyopens in a new tab or window meeting.

Disclosures

All studies were supported by Eisai.

Reyderman and Irizarry are Eisai employees.

Van Dyck reported relationships with Roche, Eisai, Ono Pharmaceuticals, Cerevel, Bristol Myers Squibb, UCB, Eli Lilly Janssen Pharmaceuticals, Biogen, and Genentech.

Primary Source

Alzheimer's Association International Conference

Source Reference: opens in a new tab or windowReyderman L "Lecanemab subcutaneous formulation for maintenance dosing in early Alzheimer's disease" AAIC 2025; Abstract 104693.

Secondary Source

Alzheimer's Association International Conference

Source Reference: opens in a new tab or windowIrizarry M "Safety profile of a subcutaneous lecanemab formulation" AAIC 2025.

Additional Source

Alzheimer's Association International Conference

Source Reference: opens in a new tab or windowvan Dyck C "The lecanemab CLARITY AD open-label extension in early Alzheimer's disease: Initial findings from the 48-month analysis" AAIC 2025.

https://www.medpagetoday.com/meetingcoverage/aaic/116807

Kugler’s sudden exit from Fed accelerates Powell succession planning: UBS

 The unexpected resignation of Federal Reserve Governor Adriana Kugler on Friday has fast-tracked the search for a successor to Chair Jerome Powell, an opening that could reshape the central bank’s leadership far sooner than anticipated, according to economists at financial-services firm UBS.

“Governor Kugler's seat opening up sooner than expected will move the search for the next chair into overdrive,” Amanda Wilcox, economist at UBS, wrote in a note on Friday.

Kugler will step down effective Aug. 8, the Fed announced late Friday afternoon. Appointed in September 2023 to fill an unexpired term through January 2026, she missed last week’s Federal Open Market Committee meeting for personal reasons.

Her early exit, just shy of two years on the board, comes at a critical moment as the White House weighs options for Powell’s eventual successor.

“We have long expected that Chair Powell's replacement as chair would first be appointed to fill Governor Kugler's seat, once her term was over,” Wilcox said. “Then, when Chair Powell's term as chair was over in May 2026, the appointee who replaced Kugler as governor would be elevated to be the next chair.”

President Donald Trump has made no secret of his frustration with Fed Chair Powell, who has resisted the administration’s push for aggressive interest rate cuts amid concerns that Trump's tariffs could spur a cycle of Biden-era inflation. Trump has publicly criticized Powell for maintaining rates above what he believes is necessary to fuel economic growth and has privately floated the idea of firing or demoting him, an unprecedented move that would test the legal and political independence of the central bank.

Because the chair must also be a sitting governor, the early opening now gives the White House a chance to install a successor well ahead of Powell's term ending, potentially avoiding complications if Powell chooses to remain on the board through 2028, when his term as Governor officially ends, according to UBS.

“Governor Kugler's seat opening up sooner than expected will move the search for the next chair into overdrive,” Wilcox said. “The White House now has the opportunity to submit a nomination to the Board of Governors imminently. The potentially extended duration of having the heir apparent in place alongside the current Chair could make communications complicated, and lead to additional tension on the FOMC.”

That tension may already be emerging. This week’s meeting of the Federal Open Market Committee included two dissents, marking the first time since 1993 that two governors dissented in the same meeting.

Potential successors to Powell have been floated in both media and policy circles.

“Names of a number of candidates have been circulating in the news media, including in a Wall Street Journal article in June,” Wilcox noted. “Treasury Secretary Scott Bessent, NEC Director Kevin Hassett and former Governor Kevin Warsh have all been mentioned. We suspect that Governor Waller, one of this week's two dissenters in favor of a 25-basis-point cut, could be in contention too.”

While UBS refrained from speculating on the administration’s final decision, Wilcox added: “We look forward to watching the process, especially as the timeline seems to have accelerated in light of this afternoon's resignation.”

Governor Kugler’s early departure leaves seven seats on the Fed’s board of governors, with the White House now under pressure to nominate someone who could take over the chairmanship in 2026, if not sooner.

https://www.msn.com/en-us/money/markets/kugler-s-sudden-exit-from-fed-accelerates-powell-succession-planning-ubs/ar-AA1JPQvK

2 Charged For Nationwide Fraud Scheme Targeting Hundreds Of Elderly Victims

 Jingbin Jiang and Su Jian Liu Are Charged With Participating in a Scheme That Attempted to Steal Over $18 Million From Over 350 Victims

United States Attorney for the Southern District of New York, Jay Clayton; Assistant Director in Charge of the New York Field Office of the Federal Bureau of Investigation (“FBI”), Christopher G. Raia; and Commissioner of the New York City Police Department (“NYPD”), Jessica S. Tisch,  announced charges against JINGBIN JIANG and SU JIAN LIU, a/k/a “Fatty,” a/k/a “Ah Pang,” for a scheme to defraud elderly victims across the United States, which attempted to steal over $18 million from over 350 victims and resulted in actual losses of over $5 million to over 70 victims.  JIANG was arrested in Staten Island this morning and will be presented today before U.S. Magistrate Judge Stewart D. Aaron.  LIU is still at large.  The case is assigned to U.S. District Judge Mary Kay Vyskocil.

“As alleged, Jingbin Jiang and Su Jian Liu worked together with others to steal the hard-earned money of some our most vulnerable New Yorkers and others around the country,” said U.S. Attorney Jay Clayton.  “Taking advantage of our elderly after they have worked so hard to save and contributed so much to our city and this country is heartless and despicable.  These charges, and the efforts of the FBI and the NYPD, should serve as a warning to fraudsters and cybercriminals: New Yorkers want you held accountable for your crimes, and the women and men of our Office are committed to doing so.”

“Jingbin Jiang and Su Jian Liu allegedly defrauded elderly victims of more than $5 million by utilizing extortionate tactics to coerce withdrawals of significant cash or purchases of gold,” said FBI Assistant Director Christopher G. Raia.  “This alleged conspiracy wielded fear of bankruptcy and arrest to ensure victims complied with the unlawful requests for money.  The FBI is committed to apprehending any individual who utilizes online platforms to target and exploit vulnerable victims across the country.”

“These defendants allegedly led a nationwide fraud scheme with the goal of targeting innocent, elderly victims and stealing millions of their hard-earned savings,” said NYPD Commissioner Jessica S. Tisch.  “Jingbin Jiang and Su Jian Liu allegedly participated in a plot involving elaborate, fictitious narratives to manipulate elderly victims and trick them into participating in their scheme, which involved attempts to steal over $18 million from 350 people.  I am grateful to the members of the NYPD, FBI, and the U.S. Attorney’s Office for holding these alleged predatory fraudsters accountable.”

According to the allegations in the Indictment unsealed today in Manhattan federal court:[1]

Between at least in or about 2023 and in or about July 2025, JIANG and LIU participated with others in a fraudulent scheme that primarily targeted elderly victims located all across the United States, including in New York, New Jersey, Pennsylvania, Massachusetts, Texas, Washington, Wisconsin, California, Connecticut, Arizona, North Carolina, South Carolina, Missouri, Mississippi, Kentucky, Utah, Oregon, Colorado, and Montana.

The scheme proceeded in the following manner: First, victims would typically see a pop-up message on their computers indicating that they needed to call a particular phone number controlled by members of the scheme.  The pop-up message would typically claim to come from a technology company, a bank, or the government.  Second, when victims called the phone number, they were told a fictitious narrative that would ultimately lead to a suggestion that the victims withdraw money from their bank account.  For example, some victims were falsely told that their computers had a virus, or that their computers had been hacked into and used to commit serious crimes, like downloading child sexual abuse material.  Others were falsely told that their bank accounts had been compromised and were vulnerable to unauthorized withdrawals.  To avoid arrest or protect their bank accounts from being compromised, victims were instructed to withdraw large amounts of cash from their bank accounts or purchase large quantities of gold.  Some victims were even told that their money would be safely held in the custody of a consumer protection agency like the Federal Trade Commission, and they were sent notices on fake federal government letterhead purporting to bear the signature of a federal government official:

Third, many victims were told that a courier would be arriving at their home (or other coordinated pick-up location) to retrieve the gold and/or cash.  Victims were often provided with the courier’s name (which was fictitious), a description of the courier’s clothing, and sometimes a password, purportedly to ensure the courier was authorized to pick up the gold and/or cash.  Other victims were told to purchase and transfer cryptocurrency or gift cards, which did not require a courier.  Victims were typically under the impression that this gold and/or cash would then be deposited, on the victims’ behalf, into a new, safe, uncompromised bank account (or with the Federal Trade Commission, as noted above) that they could access without concern in the future.  In reality, these funds were stolen and never returned to the victims.  Some victims engaged in multiple transactions before realizing the fraudulent nature of the scheme.

JIANG and LIU participated in the scheme by managing and supervising the couriers that traveled to meet the victims to pick up the cash and gold, which was then transported back to New York City.  JIANG and LIU received information about potential victims from other members of the scheme on text-messaging platforms, in messages that typically included the zip codes and the amounts of cash or gold to be collected from each victim. JIANG and LIU could then decide whether to accept the pick-up, and if they did, the other members of the scheme would provide more specific details about the victim and when and where to pick up the cash or gold.  After arranging for couriers to make the pick-ups, JIANG and LIU would provide updates to other members of the scheme about the couriers’ progress.  After the victims provided the criminal proceeds to the couriers, JIANG and LIU arranged for the criminal proceeds to be distributed to other members of the scheme, including by converting cash and gold into cryptocurrency to be easily transmitted to members of the scheme located overseas, including in India and China.  In total, members of the conspiracy have attempted to steal at least approximately $18 million from over 350 victims, and they have successfully stolen at least approximately $5 million from over 70 victims.

If you or someone you know has been victimized by this scheme, please file a complaint with the FBI’s Internet Crime Complaint Center, which is available at ic3.gov.

*                *                *

JIANG, 37, of Staten Island, New York, and LIU, 38 of Edmond, Oklahoma, are both charged with one count of wire fraud conspiracy, which carries a maximum sentence of 20 years in prison; and one count of conspiracy to commit interstate transportation of stolen property, which carries a maximum sentence of five years in prison.

The maximum potential sentences in this case are prescribed by Congress and provided here for informational purposes only, as any sentencing of the defendants will be determined by the judge.

Mr. Clayton praised the investigative work of the FBI and NYPD’s Joint Organized Crime Task Force.  Mr. Clayton also thanked the New York State Police and the Bedford Police Department for their assistance in the investigation of this case.

This case is being handled by the Office’s Violent & Organized Crime Unit. Assistant U.S. Attorneys Andrew K. Chan and Angela Zhu are in charge of the prosecution. 

The charges contained in the Indictment are merely accusations, and the defendants are presumed innocent unless and until proven guilty.

u.s._v._jiang_and_liu_indictment.pdf

https://www.justice.gov/usao-sdny/pr/two-men-charged-nationwide-fraud-scheme-targeting-hundreds-elderly-victims