By Ernie Mundell HealthDay Reporter<\/b><\/p>\n
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WEDNESDAY, Jan. 31, 2024 (HealthDay News) — Biogen, maker of the Alzheimer’s medicine Aduhelm<\/a>, announced Wednesday that it would “discontinue the development and commercialization” of the controversial drug.<\/p>\n Biogen will return the rights to Aduhelm to Neurimmune, the private firm that invented it, the company said in a statement<\/a>.<\/p>\n It’s a sobering new chapter for the drug, which first gained U.S. Food and Drug Administration approval in 2021. Some hailed Aduhelm as the first new medication for Alzheimer’s disease in decades.<\/p>\n But many others questioned Aduhelm’s safety and effectiveness, and Medicare refused to cover the drug’s high cost because of doubt over its effectiveness. Initially, a year’s supply of Aduhelm was priced at $56,000, but after widespread criticism Biogen cut that price in half.<\/p>\n The drug still has its supporters. In a statement<\/a>, the Alzheimer’s Association (AA) called Aduhelm’s 2021 approval “a landmark event for the Alzheimer s field and, most importantly, [it] provided hope for the millions of people living with early Alzheimer s, and their families.”<\/p>\n The AA put some of the blame for Aduhelm’s downfall on federal agencies.<\/p>\n The U.S. Centers for Medicare and Medicaid Services “denied Medicare coverage to this treatment — approved by the FDA using the accelerated approval pathway — unless the patient was enrolled in a clinical trial,” the AA said. “We believe this contributed to limiting the number of people living with Alzheimer s, a fatal disease, who could get access to the approved treatment, and created significant confusion for patients and doctors.”<\/p>\n For its part, Biogen said it will shift its focus to a newer Alzheimer’s drug, Leqembi, which it markets in a partnership with Japan-based Eisai. Leqembi received FDA approval last year. <\/p>\n For people still taking Aduhelm, the AA had some advice.<\/p>\n “The Alzheimer s Association recommends that people receiving Aduhelm through a clinical trial or by prescription, and their families, should connect with their study contact and\/or their personal health care provider to talk through how these changes will impact their treatment and care,” the organization said.<\/p>\n More information<\/strong><\/p>\n The U.S. Centers for Disease Control and Prevention has more on Alzheimer’s disease<\/a>.<\/p>\n SOURCES: Biogen Inc., news release, Jan. 31, 2024; Alzheimer’s Association, news release, Jan. 31, 2024<\/p>\n <\/i><\/p>\n