EMA Recommends EU Approval for Alzheimer's Drug Kisunla

The European Medicines Agency EMA changes its mind and now recommends the EU Commission to approve the medicine Kisunla for early Alzheimer's disease, reports Läkartidningen.

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EMA Recommends EU Approval for Alzheimer's Drug Kisunla
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The drug Kisunla (with the substance donanemab) is an antibody that can to some extent slow down the development for patients in the disease's early stage. The agent should, however, have a modest effect and can, according to studies, slow down the disease by about seven months.

The medicine was approved by the American drug authority FDA last year. As recently as in March this year, the European authority EMA said no to the drug with the argument that the benefit of the treatment did not outweigh the risks of serious and in the worst case fatal side effects, such as swelling and bleeding in the brain.

The pharmaceutical company Eli Lilly then requested a reassessment, and EMA has now changed its stance in the matter.

The recommendation will now be reviewed by the EU Commission, which is expected to make the final decision within the next few months.

Kisunla is the second drug of its kind on the market in the USA since the substance lecanemab, which is partly based on a Swedish discovery, was approved and sold under the name Leqembi. In November last year, the substance was approved by EMA.

Alzheimer's is an incurable dementia disease that about 100,000 Swedes live with. Most of those affected are over 65 years old.

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By TTEnglish edition by Sweden Herald, adapted for local and international readers

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