In reversal, FDA calls for limits on people who receive Alzheimer’s drug

When the FDA Aduhelm approved a month ago his original label had said the drug was “for the treatment of Alzheimer’s disease”. The surprisingly wide label caused a storm of worry among many Alzheimer’s disease experts, even those who had supported the drug’s approval.

At a forum last month sponsored by the Alzheimer’s Association, which had pushed for approval of Aduhelm, a panel of clinicians with Alzheimer’s disease with differing views on drug approval s ‘is nonetheless united in saying that its use should be severely limited.

Many experts say the drug’s label should not only restrict the use of Aduhelm to mild stages of the disease, but should also require two other strict conditions from clinical trials: that eligible patients have evidence of high levels. of a key protein, amyloid, in their brain, and that people with certain medical conditions (called ‘contraindications’) should be prevented from taking the drug, or at least designated as a high risk group, because it can cause swelling and hemorrhage of the brain.

At the forum, Dr Stephen Salloway, director of the Memory and Aging program at Butler Hospital in Providence, RI, who helped lead the Aduhelm trials and is one of the drug’s most passionate medical champions, said that when he saw that the label did not include any contraindications, his reaction was “oy”.

On Thursday, Dr Lon Schneider, director of California Alzheimer’s Disease Center at the University of Southern California, who also worked on one of Aduhelm’s trials and opposed approval of the drug, said the new labeling was insufficient.

Among other things, the label should have indicated, he said, that people with diabetes, high blood pressure and those taking blood thinners were not allowed to participate in clinical trials and that, therefore, “We increased risk” for these patients.