European regulators have finally approved the Alzheimer’s treatment Leqembi after an advisory committee initially rejected the drug last summer and then reconsidered it.
The infused treatment from Japanese drugmaker Eisai and Biogen received approval for patients in early stages of the fatal, mind-robbing disease. The decision applies to all 27 members of the European Union plus Norway, Iceland and Liechtenstein, the drugmakers said late Tuesday.
The European Committee for Medicinal Products for Human Use initially said last July that the drug should not receive marketing approval due to concerns about its side effects. Those include brain bleeding and swelling, which can be dangerous in rare cases.
Eisai asked the committee to reconsider its decision, and it then recommended approval in November.
Leqembi clears a sticky brain plaque linked to the disease. A large study has shown that it slowed memory and thinking decline by several months in those who received the treatment compared to those who got a dummy drug.
The drug was approved in Europe for patients with the brain plaque and one or no copies of a certain gene, making them less likely to experience side effects.
The European approval confirms Leqembi's positive risk-benefit profile, TD Cowen analyst Phil Nadeau said in a research note. But he added that the drug's European debut will likely be slow, developing over several years.
Eisai developed Leqembi and is co-marketing it with Cambridge, Massachusetts-based Biogen Inc.
The drug and a competing treatment, Kisunla, from Eli Lilly and Co. are the first to convincingly show a delay in cognitive decline for patients. Both have both been approved by U.S. regulators.
But the European committee said last month that Kisunla shouldn’t receive approval due to side effect concerns. Indianapolis-based Lilly said it hopes to continue discussing the drug through a decision reexamination.
Biogen shares rose about 25 cents to $117.23 in midday trading Wednesday while broader indexes slipped.
FILE - The Biogen Inc., headquarters is pictured on March 11, 2020, in Cambridge, Mass. (AP Photo/Steven Senne, File)
BANGKOK (AP) — Thai officials on Wednesday said they seized 238 tons of illegally imported electronic waste from the United States at the port of Bangkok, one of the biggest lots they've found this year.
The waste, which came in 10 large containers, was declared as mixed metal scrap but turned out to be circuit boards mixed in a huge pile of metal scrap, said Theeraj Athanavanich, director-general of the Customs Department.
The waste was found on Tuesday after the containers became the subject of a routine random inspection, officials said.
A U.N. report last year said electronic waste is piling up worldwide. Some 62 million tons of electronic waste was generated in 2022 and that figure is on track to reach 82 million tons by 2030, the report said. It said only 22% of the waste was properly collected and recycled in 2022 and that quantity is expected to fall to 20% by the end of the decade due to higher consumption, limited repair options, shorter product life cycles, and inadequate management infrastructure.
Theeraj said Thai authorities are looking to press charges including falsely declaring imported goods, illegally importing electronic waste and planning to re-export the waste back to its country of origin.
“It’s important that we take action on this kind of goods,” he said. “There are environmental impacts that are dangerous to the people, especially communities around factories that might import these things for processing, then recycling.”
Electronic waste creates huge health hazards. Many components are laden with lead and mercury, cadmium and other toxins. Recyclers are after gold, silver, palladium and copper, mainly from printed circuit boards, but lax controls mean that facilities often burn plastics to release encased copper and use unsafe methods to extract precious metals.
Thailand passed a ban on the import of a range of electronic waste products in 2020. The Cabinet in February approved an expanded list of the banned waste.
Sunthron Kewsawang, deputy director-general of the Department of Industrial Works, said officials suspected at least two factories in Samut Sakhon province, which borders Bangkok, are involved in importing the waste.
In January, the Customs Department said it seized 256 tons of illegally imported electronic waste from Japan and Hong Kong at a port in eastern Thailand.
A Thai official shows samples of illegally imported electronic waste from the United States which they said they seized at Bangkok Port during a press conference in Bangkok, Thailand, Wednesday, May 14, 2025. (AP Photo/Sakchai Lalit)
Thai officials display samples of illegally imported electronic waste from the United States which they said they seized at Bangkok Port during a press conference in Bangkok, Thailand, Wednesday, May 14, 2025. (AP Photo/Sakchai Lalit)
Thai officials show samples of illegally imported electronic waste from the United States which they said they seized at Bangkok Port during a press conference in Bangkok, Thailand, Wednesday, May 14, 2025. (AP Photo/Sakchai Lalit)
A Thai official shows a sample of illegally imported electronic waste from the United States which they said they seized at Bangkok Port during a press conference in Bangkok, Thailand, Wednesday, May 14, 2025. (AP Photo/Sakchai Lalit)
