Label for Biogen’s Leqembi not barrier to treatment, says William Blair

William Blair keeps an Outperform rating on Biogen after the FDA granted full approval to Leqembi to treat Alzheimer’s disease. The full approval label is largely consistent with that from the accelerated approval label, with the most obvious addition being a black box warning of the increased risk of symptomatic and serious ARIA in ApoE4 homozygous patients and calls for genetic testing to determine ApoE status prior to initiating treatment, the analyst tells investors in a research note. The firm believes commercially available genotyping should already be part of the patient workup if Leqembi is to be considered and should not be a barrier to treatment. Blair views the approval as a positive and says it opens a path to material reimbursement for Leqembi, which could provide Biogen its “next growth pillar” under the Eisai profit share agreement. The firm models global sales of more than $8B in 2030.