EU Rejects Donanemab Alzheimer's Drug Over Safety Risks
The European Medicines Agency denies approval for Donanemab, emphasizing safety concerns for early-stage Alzheimer's patients.
On March 29, 2025, the European Medicines Agency (EMA) announced that it would not grant approval for the Alzheimer's drug Donanemab, citing substantial safety risks that outweigh potential benefits for patients in the early stages of the disease.
The EMA's decision followed a thorough evaluation of the medication, which is associated with serious adverse effects, including brain swelling and bleeding.
Experts within the agency determined that these risks are significant enough to preclude approval, particularly as the drug is designed to slow disease progression rather than provide a cure.
Donanemab, marketed under the name Kisunla, has already secured approval in markets including the United States, Japan, China, and the United Kingdom.
It is aimed at individuals diagnosed with early-stage Alzheimer's disease, a condition that currently affects over one million people in Germany alone.
In contrast to Donanemab, the EMA previously approved Lecanemab, marking it as the first drug in Europe intended to alter the course of Alzheimer's disease.
However, the final decision on Lecanemab's broader availability within the EU awaits action from the European Commission, which has yet to make a determination on the EMA's recommendations.
The EMA had initially expressed concerns regarding Lecanemab's safety profile, noting that the risk of severe side effects could exceed the anticipated benefits.
Following revisions to the application, including the incorporation of subgroup analyses from a limited study, experts reassessed the drug's overall benefit-risk balance, ultimately finding it favorable for certain patient groups.
As of now, no drug has received approval in the EU that specifically targets the underlying progression of Alzheimer's disease, despite ongoing research efforts and evolving developments within the field of dementia treatment.
The EMA's decision followed a thorough evaluation of the medication, which is associated with serious adverse effects, including brain swelling and bleeding.
Experts within the agency determined that these risks are significant enough to preclude approval, particularly as the drug is designed to slow disease progression rather than provide a cure.
Donanemab, marketed under the name Kisunla, has already secured approval in markets including the United States, Japan, China, and the United Kingdom.
It is aimed at individuals diagnosed with early-stage Alzheimer's disease, a condition that currently affects over one million people in Germany alone.
In contrast to Donanemab, the EMA previously approved Lecanemab, marking it as the first drug in Europe intended to alter the course of Alzheimer's disease.
However, the final decision on Lecanemab's broader availability within the EU awaits action from the European Commission, which has yet to make a determination on the EMA's recommendations.
The EMA had initially expressed concerns regarding Lecanemab's safety profile, noting that the risk of severe side effects could exceed the anticipated benefits.
Following revisions to the application, including the incorporation of subgroup analyses from a limited study, experts reassessed the drug's overall benefit-risk balance, ultimately finding it favorable for certain patient groups.
As of now, no drug has received approval in the EU that specifically targets the underlying progression of Alzheimer's disease, despite ongoing research efforts and evolving developments within the field of dementia treatment.
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