FDA grants accelerated approval to new Alzheimer’s drug

The Food and Drug Administration (FDA) has approved a new drug to treat Alzheimer’s disease, according to the American Hospital Association. Developed by drugmaker Biogen, Aduhelm is the first medication approved for the treatment of Alzheimer’s since 2003. The controversial approval has sparked fierce debates as the approval comes after an independent advisory committee recommended that the agency reject the drug, according to CBS News.

According to Politico, Aduhelm’s proponents are hopeful that the drug will be the first to slow the progression of Alzheimer’s disease, which affects over six million older adults. Critics, including several experts on the advisory committee, say that the clinical trials did not conclusively prove the drug’s effectiveness.

At an eye-popping $56,000 per year, Aduhelm also threatens to blow a hole in the Medicare budget, with millions of potential patients who would take the medication for years, according to the New York Times. And Medicare would also be on the hook for additional costs, like expensive brain scans and in-person visits to administer the drug intravenously. Costs to patients could also be considerable — Medicare enrollees who do not purchase supplemental coverage could be responsible for more than $11,000 in out-of-pocket costs for Aduhelm.

Still, new drug options represent hope for individuals with Alzheimer’s and their loved ones. According to Reuters, Eli Lilly and Co. will also seek approval for its rival drug donanemab, which, like Aduhelm, works to remove sticky clumps of beta amyloid protein from the brain.