WASHINGTON: The US Food and Drug Administration on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in the early stages of Alzheimer’s disease.
The FDA approval of the drug, Leqembi, also known as lecanemab, came just days after the agency was harshly criticized in a congressional report for its green-lighting of another Alzheimer’s drug, Aduhelm.
And it was granted despite trial results showing the monoclonal antibody treatment carries risks of brain swelling and bleeding.
Both drugs were approved by the FDA through an accelerated process that allows the US regulatory agency to fast-track approval of drugs for serious conditions where there is an unmet medical need.
Leqembi and Aduhelm, which were both jointly developed by Japan’s Eisai and Biogen of the United States, “represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease,” the FDA said in a statement.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Billy Dunn of the FDA’s Center for Drug Evaluation and Research said in a statement.
Leqembi is “the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Dunn said.
Preliminary data from a trial of Leqembi was released in September and found it slowed cognitive decline in Alzheimer’s patients by 27 percent.
The phase three trial involved nearly 1,800 people, divided between those given the drug and given a placebo, and ran over 18 months.
The complete trial data, published in the New England Journal of Medicine, fleshed out the findings but also raised concern about the incidence of “adverse effects” including brain bleeds and swelling.
The results showed that 17.3 percent of patients administered the drug experienced brain bleeds, compared with nine percent of those receiving a placebo.
And 12.6 percent of those taking the drug experienced brain swelling, compared with just 1.7 percent of those in the placebo group.
Deaths were reported at approximately the same rate in both arms of the trial of the drug.
In Alzheimer’s disease, two key proteins, tau and amyloid beta, build up into tangles and plaques, known together as aggregates, which cause brain cells to die and lead to brain shrinkage.
Leqembi works by targeting amyloid.
Biogen and Eisai previously brought Aduhelm to market, but there was significant controversy over whether it worked, and its approval in 2021 led to three high-level resignations in the FDA.
An 18-month US congressional investigation said the approval process for Aduhelm was “rife with irregularities” and criticized both the agency and Biogen.
The Cambridge, Massachusetts-based Biogen set an “unjustifiably high price” for Aduhelm of $56,000 a year, the congressional report said.
Eisai said Leqembi would be priced initially at $26,500 per year.
US approves new drug to treat Alzheimer’s
https://arab.news/8eh7g
US approves new drug to treat Alzheimer’s
- Leqembi is “the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease”.
Reference to Trump’s impeachments is removed from the display of his Smithsonian photo portrait
- For now, references to Presidents Andrew Johnson and Bill Clinton being impeached in 1868 and 1998, respectively, remain as part of their portrait labels, as does President Richard Nixon’s 1974 resignation as a result of the Watergate scandal
WASHINGTON: President Donald Trump’s photo portrait display at the Smithsonian’s National Portrait Gallery has had references to his two impeachments removed, the latest apparent change at the collection of museums he has accused of bias as he asserts his influence over how official presentations document US history.
The wall text, which summarized Trump’s first presidency and noted his 2024 comeback victory, was part of the museum’s “American Presidents” exhibition. The description had been placed alongside a photograph of Trump taken during his first term. Now, a different photo appears without any accompanying text block, though the text was available online. Trump was the only president whose display in the gallery, as seen Sunday, did not include any extended text.
The White House did not say whether it sought any changes. Nor did a Smithsonian statement in response to Associated Press questions. But Trump ordered in August that Smithsonian officials review all exhibits before the nation celebrates the 250th anniversary of the Declaration of Independence on July 4. The Republican administration said the effort would “ensure alignment with the president’s directive to celebrate American exceptionalism, remove divisive or partisan narratives, and restore confidence in our shared cultural institutions.”
Trump’s original “portrait label,” as the Smithsonian calls it, notes Trump’s Supreme Court nominations and his administration’s development of COVID-19 vaccines. That section concludes: “Impeached twice, on charges of abuse of power and incitement of insurrection after supporters attacked the US Capitol on January 6, 2021, he was acquitted by the Senate in both trials.”
Then the text continues: “After losing to Joe Biden in 2020, Trump mounted a historic comeback in the 2024 election. He is the only president aside from Grover Cleveland (1837– 1908) to have won a nonconsecutive second term.”
Asked about the display, White House spokesman Davis Ingle celebrated the new photograph, which shows Trump, brow furrowed, leaning over his Oval Office desk. Ingle said it ensures Trump’s “unmatched aura ... will be felt throughout the halls of the National Portrait Gallery.”
The portrait was taken by White House photographer Daniel Torok, who is credited in the display that includes medallions noting Trump is the 45th and 47th president. Similar numerical medallions appear alongside other presidents’ painted portraits that also include the more extended biographical summaries such as what had been part of Trump’s display.
Sitting presidents are represented by photographs until their official paintings are commissioned and completed.
Ingle did not answer questions about whether Trump or a White House aide, on his behalf, asked for anything related to the portrait label.
The gallery said in a statement that it had previously rotated two photographs of Trump from its collection before putting up Torok’s work.
“The museum is beginning its planned update of the America’s Presidents gallery which will undergo a larger refresh this Spring,” the gallery statement said. “For some new exhibitions and displays, the museum has been exploring quotes or tombstone labels, which provide only general information, such as the artist’s name.”
For now, references to Presidents Andrew Johnson and Bill Clinton being impeached in 1868 and 1998, respectively, remain as part of their portrait labels, as does President Richard Nixon’s 1974 resignation as a result of the Watergate scandal.
And, the gallery statement noted, “The history of Presidential impeachments continues to be represented in our museums, including the National Museum of American History.”
Trump has made clear his intentions to shape how the federal government documents US history and culture. He has offered an especially harsh assessment of how the Smithsonian and other museums have featured chattel slavery as a seminal variable in the nation’s development but also taken steps to reshape how he and his contemporary rivals are depicted.
In the months before his order for a Smithsonian review, he fired the head archivist of the National Archives and said he was firing the National Portrait Gallery’s director, Kim Sajet, as part of his overhaul. Sajet maintained the backing of the Smithsonian’s governing board, but she ultimately resigned.
At the White House, Trump has designed a notably partisan and subjective “Presidential Walk of Fame” featuring gilded photographs of himself and his predecessors — with the exception of Biden, who is represented by an autopen — along with plaques describing their presidencies.
The White House said at the time that Trump himself was a primary author of the plaques. Notably, Trump’s two plaques praise the 45th and 47th president as a historically successful figure while those under Biden’s autopen stand-in describe the 46th executive as “by far, the worst President in American History” who “brought our Nation to the brink of destruction.”
