Biogen's Alzheimer's therapy Aduhelm gets updated warning on brain hemorrhage risk
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The FDA has updated the labeling for Biogen's (NASDAQ:BIIB) Alzheimer's therapy Aduhelm (aducanumab) that tells healthcare providers to warn patients that intracerebral hemorrhage has been reported with its use.
"Inform patients that although [brain swelling] can occur in any patient treated with ADUHELM, there is an increased risk in patients who are ApoE Îµ4 homozygotes, and that there is a test available to determine ApoE Îµ4 genotype," the section Patient Counseling Information in the labeling reads.

The updated labeling is not likely to impact sales much considering they are already quite low as Medicare and private insurers don't cover it.
Biogen (BIIB) also has Leqembi (lecanemab), its newer Alzheimer's therapy, though CMS has yet to issue a National Coverage Determination for it.
Biogen (BIIB) releases its latest quarterly results on Wednesday before the market open.