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”.
Italian police fire tear gas as protesters clash near Winter Olympics hockey venue
- Police vans behind a temporary metal fence secured the road to the athletes’ village, but the protest veered away, continuing on a trajectory toward the Santagiulia venue
MILAN: Italian police fired tear gas and a water cannon at dozens of protesters who threw firecrackers and tried to access a highway near a Winter Olympics venue on Saturday.
The brief confrontation came at the end of a peaceful march by thousands against the environmental impact of the Games and the presence of US agents in Italy.
Police held off the violent demonstrators, who appeared to be trying to reach the Santagiulia Olympic ice hockey rink, after the skirmish. By then, the larger peaceful protest, including families with small children and students, had dispersed.
Earlier, a group of masked protesters had set off smoke bombs and firecrackers on a bridge overlooking a construction site about 800 meters (a half-mile) from the Olympic Village that’s housing around 1,500 athletes.
Police vans behind a temporary metal fence secured the road to the athletes’ village, but the protest veered away, continuing on a trajectory toward the Santagiulia venue. A heavy police presence guarded the entire route.
There was no indication that the protest and resulting road closure interfered with athletes’ transfers to their events, all on the outskirts of Milan.
The demonstration coincided with US Vice President JD Vance’s visit to Milan as head of the American delegation that attended the opening ceremony on Friday.
He and his family visited Leonardo da Vinci’s “The Last Supper” closer to the city center, far from the protest, which also was against the deployment of US Immigration and Customs Enforcement agents to provide security to the US delegation.
US Homeland Security Investigations, an ICE unit that focuses on cross-border crimes, frequently sends its officers to overseas events like the Olympics to assist with security. The ICE arm at the forefront of the immigration crackdown in the US is known as Enforcement and Removal Operations, and there is no indication its officers are being sent to Italy.
At the larger, peaceful demonstration, which police said numbered 10,000, people carried cardboard cutouts to represent trees felled to build the new bobsled run in Cortina. A group of dancers performed to beating drums. Music blasted from a truck leading the march, one a profanity-laced anti-ICE anthem.
“Let’s take back the cities and free the mountains,” read a banner by a group calling itself the Unsustainable Olympic Committee. Another group called the Association of Proletariat Excursionists organized the cutout trees.
“They bypassed the laws that usually are needed for major infrastructure project, citing urgency for the Games,” said protester Guido Maffioli, who expressed concern that the private entity organizing the Games would eventually pass on debt to Italian taxpayers.
Homemade signs read “Get out of the Games: Genocide States, Fascist Police and Polluting Sponsors,” the final one a reference to fossil fuel companies that are sponsors of the Games. One woman carried an artificial tree on her back decorated with the sign: “Infernal Olympics.”
The demonstration followed another last week when hundreds protested the deployment of ICE agents.
Like last week, demonstrators Saturday said they were opposed to ICE agents’ presence, despite official statements that a small number of agents from an investigative arm would be present in US diplomatic territory, and not operational on the streets.
