EU Backs Leqembi: A Breakthrough in Alzheimer's Treatment

The European Union's drugs regulator has recommended approval for Eisai and Biogen's Alzheimer's drug Leqembi. This marks a potential first treatment approval in the EU for early Alzheimer's, focusing on patients without the ApoE4 gene variant. The decision hinges on European Commission and state-level acceptance.

The European Union drugs regulator has taken a significant step by recommending approval of Leqembi, an Alzheimer's drug developed by Eisai and Biogen. This decision could lead to Leqembi becoming the first approved Alzheimer's treatment in the EU if acecepted by the European Commission and widely adopted by member states.

The drug's approval is recommended for patients with either one or no copy of the ApoE4 gene variant, which is usually linked to earlier onset of Alzheimer's. If granted marketing authorization, individual EU member states will decide on the pricing and reimbursement, considering each national health system's context and potential use of Leqembi.

In the EU regulator's re-examination, benefits of the drug were found to outweigh the risks, particularly brain swelling, in patients with fewer ApoE4 genes. Health experts are optimistic, seeing it as a ray of hope for millions of EU patients and their families after previous concerns about the drug's risk of brain swelling.

(With inputs from agencies.)