08:11 AM EDT, 09/24/2025 (MT Newswires) -- Biogen (BIIB) and Eisai said Wednesday that Australia's Therapeutic Goods Administration approved Leqembi for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease.

The approval follows a review process after the regulatory agency initially did not approve the drug in February, the company said.

Leqembi targets toxic protofibrils and amyloid plaques associated with Alzheimer's disease, and the drug is indicated for patients who are non-carriers or heterozygous carriers of the ApoE gene, Biogen said.

Biogen shares were up 1% in recent premarket activity.