A drug for treating Alzheimer's disease in early stages is close to authorization in the EU. What is Donnemab
Alzheimer's disease, analyzed in the tomographs of some patients, photo: Felipe Caparros Cruz / Dreamstime.com
A new drug developed for the treatment of Alzheimer's disease in early stages is close to authorization in the European Union, after a favorable decision in this regard of an expert committee within the European Medicines Agency (EMA), notes News.ro.
The Committee for Human Use Medicines (CHMP) adopted on July 24, following a re-examination procedure, a positive opinion, recommending a marketing authorization for the Donenmab drug, intended for the treatment of early symptomatic forms of Alzheimer's disease in patients who are non-purifying or heterozygous for Apolipotein E ε4).
The request for authorization was submitted by the Pharmaceutical Company Eli Lilly, through the branch in the Netherlands. The authorization decision belongs to the European Commission, which usually follows the recommendations issued by the EMA.
The drug will be available as a 350 mg concentrate for infusion solution.
Donnemab is a monoclonal antibody that binds to amyloid plates and thus contributes to their elimination by microglie -mediated phagocytosis.
The decision to recommend the authorization was based on the results of clinical studies that showed that the drug has reduced the progression of the cognitive and functional deficiency associated with Alzheimer's disease.
The most common adverse reactions include imaging abnormalities associated with amyloid (area) and headache.
In April 2025, the European Commission authorized the first drug for the treatment of certain patients in the early stages of Alzheimer's disease, who have mild cognitive disorders, after an evaluation process that lasted over two years.
Photo: Felipe Caparros Cruz / Dreamstime.com
