EU Gives Green Light: Leqembi on the Verge of Alzheimer's Approval

The EU's drugs regulator recommends approval of Eisai and Biogen's Alzheimer's drug, Leqembi, for patients with early stages of the disease. The approval is limited to those with certain genetic profiles. The decision now awaits a final nod from the European Commission.

The European Union's drugs regulator has taken a pivotal step towards approving Eisai and Biogen's Alzheimer's treatment, Leqembi, for early-stage patients. This follows a previous rejection months ago due to safety concerns.

The human medicines committee within the agency endorsed Leqembi for patients with one or no copies of the ApoE4 gene—associated with earlier Alzheimer's onset. For this demographic, the committee believes the slowing of symptom progression outweighs potential risks.

The committee's favorable opinion now moves to the European Commission, which will decide on granting EU-wide marketing authorization. If approved, member states will individually decide pricing and reimbursement strategies, integrating the drug into their national health systems.

(With inputs from agencies.)