FDA approves subcutaneous Leqembi for Alzheimer’s initiation

Food and Drug Administration approved a supplemental Biologics License Application for once-weekly lecanemab subcutaneous injection as a starting dose for early Alzheimer’s disease treatment, BioArctic AB (Nasdaq Stockholm:BIOA B) announced in a press release statement Sunday. The approval allows Eisai to launch Leqembi Iqlik in late August 2026.
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Food and Drug Administration approved a supplemental Biologics License Application for once-weekly lecanemab subcutaneous injection as a starting dose for early Alzheimer’s disease treatment, BioArctic AB (Nasdaq Stockholm:BIOA B) announced in a press release statement Sunday. The approval allows Eisai to launch Leqembi Iqlik in late August 2026. The treatment is administered via autoinjector at 500 mg once weekly, delivered as two 250 mg injections of approximately 15 seconds each. Leqembi Iqlik was previously approved in the U.S.
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- Food and Drug Administration approved a supplemental Biologics License Application for once-weekly lecanemab subcutaneous injection as a starting dose for early Alzheimer’s disease treatment, BioArctic AB (Nasdaq Stockholm:BIOA B) announced in a press release statement Sunday. The approval allows Eisai to launch Leqembi Iqlik in late August 2026.
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FDA approves subcutaneous Leqembi for Alzheimer’s initiation
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