The FDA approved an at-home starting dose of Eisai and Biogen's Alzheimer's drug, Leqembi, delivered via the subcutaneous formulation Leqembi IQLIK. This allows patients or caregivers to administer injections, improving access compared to Eli Lilly's intravenous-only Kisunla. While the approval is based on clinical trials showing equivalence to the intravenous version, Citi analysts warn that adoption barriers like diagnostic confirmation and reimbursement will limit immediate commercial impact.
FDA at-home dosing approval
- ▪Biogen shares rose 4.5% in afternoon trading following the FDA approval announcement
- ▪The U.S. Food and Drug Administration approved an at-home starting dose of Eisai and Biogen's Alzheimer's drug, allowing patients to begin therapy with injections
- ▪The FDA approval allows some Alzheimer's patients to begin therapy with injections administered by themselves or a caregiver
Leqembi subcutaneous formulation
- ▪The FDA approval applies to an under-the-skin formulation of the Alzheimer's drug branded as Leqembi
- ▪Leqembi is authorized for adults with Alzheimer's disease and targets amyloid beta, a protein that forms plaques in the brain
- ▪Prior to this approval, patients starting Leqembi received the drug through intravenous infusions at a clinic and could switch to maintenance treatment after 18 months
Competitive positioning versus Kisunla
- ▪BMO Capital Markets analyst Evan Seigerman stated that Leqembi's at-home subcutaneous approval could increase uptake by improving patient access
- ▪The subcutaneous formulation of Leqembi differentiates it from Eli Lilly's Kisunla, which requires intravenous infusions
Clinical trial equivalence data
- ▪The FDA's decision was based on two earlier trials showing the intravenous version of Leqembi was effective in patients with early Alzheimer's disease
- ▪The FDA stated the subcutaneous version was not tested in separate large trials measuring patient outcomes but relied on findings showing equivalent results and similar amyloid plaque reductions compared to the infused version
Injection site adverse reactions
- ▪The injectable version of the subcutaneous Alzheimer's drug is branded as Leqembi IQLIK
- ▪Leqembi IQLIK can cause reactions at the injection area, including redness, swelling, rash, pain, or bruising
Adoption barriers remain significant
- ▪Citi analysts do not expect the FDA approval of subcutaneous Leqembi to drive an immediate commercial inflection
- ▪Citi analysts identified key adoption barriers for Leqembi, including patient identification, diagnostic confirmation, monitoring requirements, specialist availability, and reimbursement access
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