Alzheimer's drug Kisunla now approved in Europe

Kisunla, a second Alzheimer's drug, has been approved for the European market. The European Medicines Agency (EMA) originally rejected the approval because it considered the risk of life-threatening side effects too high , with limited benefits. After the manufacturer, the pharmaceutical company Eli Lilly, requested a new review, the agency changed its mind. The drug was approved with conditions.

Alzheimer's disease is still incurable. Medications can at best slow the progression somewhat. Furthermore, they are currently only suitable for a small group of sufferers.

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The active ingredient in Kisunla is donanemab. It is an antibody designed to prevent the formation of amyloid plaques (protein deposits in the brain) and partially reduce them. One hypothesis is that these plaques are the cause of nerve cell death in Alzheimer's disease. However, this view is no longer shared by all experts . Kisunla is intended to be administered to patients as an infusion every four weeks. In the manufacturer's study, this approach somewhat slowed the loss of cognitive abilities at the onset of the disease.

In April of this year, Leqembi (active ingredient lecanemab) was the first drug approved in the European Union to influence the progression of Alzheimer's disease. Lecanemab was developed by the US company Biogen in collaboration with the Japanese pharmaceutical company Eisai. Like donanemab, it is an antibody that targets the formation of protein deposits in the brain and is intended to delay the symptoms of Alzheimer's in the early stages.

During treatment with antibodies, dangerous brain swelling and bleeding can occur. Therefore, the European Medicines Agency (EMA) approved lecanemab only for very specific patients. For example, only mild cognitive impairment is allowed. Amyloid beta plaques must be detected in the brain, and genetic tests must rule out the presence of a specific gene variant that increases the likelihood of side effects. For example, no more than one copy of the gene (ApoE4) can be present, otherwise the risk of brain bleeding and swelling is increased.

Even before lecanemab was approved in Europe, the manufacturer of donanemab had also applied for European approval and submitted results from a study involving 1,736 participants. However, approval was rejected in March of this year.

Although donanemab works according to the same principle as lecanemab, the EMA initially concluded that the benefits did not outweigh the risks of the drug. This was not even the case in the small group of early-stage patients who have fewer than two copies of ApoE4. In the manufacturer's study, these patients also experienced twice as many cerebral hemorrhages and swellings under treatment with donanemab as under a placebo. Even in this lower-risk group, these complications led to dangerous complications, one of which was fatal.

On Friday, the EMA announced that the drug would be approved for the treatment of early-stage Alzheimer's disease after all. The statement stated that the manufacturer had proposed a different dosing method, starting with a lower dose of the active ingredient to reduce the risk of side effects. Furthermore, the EMA had adopted stricter rules regarding when therapy should be discontinued and which patients are eligible for treatment.

Not only must it be ruled out that patients have two copies of ApoE4, but magnetic resonance imaging (MRI) must also be used to confirm that there is no existing vascular constriction in the brain, which would make bleeding and swelling particularly dangerous.

According to Ema, the therapy should only be performed by physicians experienced in Alzheimer's treatment. The course of therapy must be conducted by a multidisciplinary team capable of detecting brain swelling and bleeding early. Furthermore, all treatments must be recorded in a central system.

But are the new medications actually suitable for many people? According to the independent Institute for Quality and Efficiency in Health Care, only one in 100 patients meets the requirements for antibody treatment. The German Society of Neurology, on the other hand, estimates, according to the news agency dpa, that antibody treatment is suitable for around ten percent of the 1.2 million people with Alzheimer's disease in Germany.