The European committee for disease control has recommended the approval of Eisai and Biogen’s medicinal product Leqembi, which is intended for the treatment of early-stage Alzheimer’s disease. Thus, the committee canceled its original four-month-old decision, reports remedium.
If the European Commission accepts the proposal, Leqembi will become the first drug in Europe for the treatment of this neurodegenerative disease.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that this medication be approved for use in certain patients.
Eisai and Biogen’s respective study involved patients who had no copies of the ApoE4 gene or carriers of the same copy. In the first and second cases, the disease manifests itself at an earlier age. Patients with two copies of that version of the gene also participated in the study.
In July, the center had denied manufacturers registration for Leqembi on the same grounds that the risk of serious brain swelling from taking it did not outweigh the drug’s modest benefit in slowing the progression of cognitive impairment.
The results of a double-blind study showed that in patients who do not have a copy of the ApoE4 gene or who carry the same copy, the slowing of Alzheimer’s progression outweighs the risk of serious brain swelling.