FDA adds warning of ‘larger areas of bleeding’ in brain to Biogen’s Aduhelm label

Zachary Brennan

Senior Editor

The FDA last week signed off on a safety-related change to the label of Biogen’s controversial Alzheimer’s drug Aduhelm, which has barely mustered any sales since its approval because payers have refused to cover it.

The new label makes clear that physicians should, “Inform patients that events of intracerebral hemorrhage greater than 1 cm in diameter have been reported infrequently in patients taking ADUHELM, and that the use of antithrombotic or thrombolytic medications while taking ADUHELM may increase the risk of bleeding in the brain.”

Brain bleeding and swelling are known side effects of Aduhelm, and the FDA investigated a death of a 75-year-old woman who experienced both. Safety data from a study reporting out in 2021 showed 41% of those in the pivotal clinical trials of the Alzheimer’s drug experienced brain bleeding and swelling.

Exclusive: FDA probing death of Aduhelm patient as Biogen’s Alzheimer’s drug continues to stir controversy
The updated label also notes (bold is updated) that:

Some people may also have small spots of bleeding in or on the surface of the brain, and infrequently, larger areas of bleeding in the brain can occur. Most people with this type of swelling in the brain do not get symptoms, however some people may have symptoms, such as: headache, nausea, confusion, difficulty walking, dizziness, vision changes, seizures.

More recently, the FDA has approved Biogen and partner Eisai’s second Alzheimer’s drug targeting amyloid Leqembi, also known as lecanemab, which is still under an accelerated approval, meaning CMS coverage remains unlikely for now but is expected to soon win full approval.

Breaking:

FDA clears second Alzheimer’s drug in ‘foundational spark’ for field. This is the second safety-related update for Aduhelm’s label, with the first coming in April 2022 to add seizures to the list of symptoms above, among other tweaks.

Biogen spokesperson Allison Parks told Endpoints via email that “this update isn’t based on any new safety risks. Rather, this is FDA bringing the Aduhelm label in line with the class of amyloid beta-directed antibodies, which at this stage includes two treatments. As you’re aware, Leqembi was approved in early January and it included this language in its label. But again, this isn’t in response to any new safety risks.”