Alzheimer’s Drug Lecanemab (Leqembi) of Greater Concern than Little-Used Aducanumab
WASHINGTON, D.C. — Biogen said on Wednesday that it would give up ownership of the controversial Alzheimer’s drug aducanumab (Aduhelm) and withdraw it from the U.S. market. In 2021, Public Citizen expressed outrage about the “indefensible decision” of the Food and Drug Administration (FDA) to grant aducanumab accelerated approval, characterizing the action as “one of the most irresponsible and egregious decisions in the history of the agency.” Aducanumab lacks clinically meaningful benefit and has a well-documented risk of potentially serious brain injury. Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group, released the following statement.
“The FDA should never have approved aducanumab. Biogen’s announcement that it will abandon the drug underscores the folly of the agency’s efforts to steamroll the product onto the market. It is a telling reminder of the pernicious effects of the inappropriately close collaboration between Biogen and the FDA before and after the company’s marketing application, which compromised the integrity of the approval process. Fortunately, very few patients were prescribed aducanumab.
“Of greater concern is lecanemab (Leqembi), Biogen’s second drug for Alzheimer’s disease, and another FDA failure. In 2023, lecanemab received full approval, despite the evidence that the drug’s clinical benefits did not outweigh its substantial health risks. The prescribing information for lecanemab includes a black box warning for brain swelling and bleeding risks. Although patients with Alzheimer’s disease and their families are desperate for better treatments, neither aducanumab, and now lecanemab, are the answer.”