The authority to regulate drugs in the European Union supports a new treatment for Alzheimer’s, returning to the initial decision to reject it.
A new treatment for Alzheimer’s photo: Shutterstock
The Committee for Human Medicines of the European Medicines Agency (EMA) issued a favorable opinion for Donnemab on Friday, July 25, a monoclonal antibody produced by the Eli Lilly pharmaceutical giant.
At the end of March, EMA evaluators said the risks do not exceed the benefits of Donenmab, which can slow down the progression of Alzheimer’s disease in an early stage, but increase the risk of swelling and brain bleeding.
A few months away, experts returned to his decision to block Alzheimer’s disease, saying that the drug may be offered to certain patients in accordance with strict safety protocols. They recommended that the drug be offered to a small group of patients with Alzheimer’s disease in an early stage, without major genetic mutations, according to Euronews.
The drug, marketed by the American company Eli Lilly under the name “Kisunla”, has already been approved in the United States, the UK, Japan and China. It targets amyloid plates in the brain, slowing cognitive decline, according to recent clinical studies.
Donnemab is a monoclonal antibody administered once a month by infusion. In a clinical study, it has shown a slowing of up to 35% of the dementia symptoms over 18 months. The treatment presents, however, significant risks, including the occurrence of potentially fatal side effects such as swelling or brain bleeding, known as area (amyloid -associated imaging abnormalities).
The committee has issued a favorable conditioned opinion, stating that the drug can only be given to Alzheimer’s incipient patients who do not have at all or have a copy of the gene associated with high risks. The administration must take place under strictly controlled conditions, with trained medical teams to detect and treat any complications promptly. Patients should also start treatment with a lower dose.
Ema said that, under these conditions, the benefits “Kisunla” exceed the risks for eligible patients.
The final decision belongs to the European Commission, which usually follows the EMA recommendations. The decision is expected to be taken in the coming months. If approved, treatment could open a new era in the fight with Alzheimer’s.
