Biogen announced Wednesday that it is stopping its clinical trials of an Alzheimer's drug, will no longer sell it, and is forsaking the ownership rights. Along with federal regulators, the company had faced major criticism over the development and pricing—at $56,000 per year—of Aduhelm. Biogen said it will press on with Leqembi, an Alzheimer's drug it developed with Eisai, the Wall Street Journal reports. Leqembi has received full approval from the Food and Drug Administration and is on the market now.
"When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed," said Christopher Viehbacher, Biogen's chief executive. "Aduhelm was that groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the field." Hopes were high when the FDA approved Aduhelm's use in 2021 that the drug could slow the disease's progression while bringing in billions in revenue. But the agency had overruled an advisory panel, and a couple of members quit over what one called a "sham process." Fears were raised that making the drug available had the potential to break Medicare.
Experts raised safety concerns, too; the drug can cause swelling or bleeding in the brain. And any benefits remain uncertain. So when Aduhelm reached the marketplace, it bombed, bringing in just only $7.8 million in its first year and a half. The saga has damaged trust in the regulatory process for new medicines, per the New York Times; a congressional inquiry raised issues including the unusually close collaboration between the company and federal regulators on Aduhelm. Eisai has said Leqembi could bring in $7 billion per year in sales by 2030. In addition, Eli Lilly is working toward FDA approval for its new drug for treating Alzheimer's, donanemab. (More Aduhelm stories.)
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