EU Regulator Approves Alzheimer’s Drug Kisunla for Select Patients

The European Medicines Agency (EMA) has reversed its earlier decision and now recommends the Alzheimer’s treatment, Kisunla, for a specific group of patients with early-stage Alzheimer’s disease. This approval comes after an expert committee concluded that the benefits of the drug can outweigh its risks if administered under strict safety protocols.

In March 2023, the EMA declared that the risks associated with donanemab, marketed as Kisunla by Eli Lilly, were too significant to endorse. The medicine has shown promise in slowing the progression of early-stage Alzheimer’s but carries the potential for serious side effects, including brain swelling and bleeding. Following a revised opinion released on Friday, the EMA stated that Kisunla could be safely offered to a narrowly defined subset of patients.

Specific Patient Criteria and Protocols

Kisunla is a monoclonal antibody administered through a once-monthly infusion. Clinical trials have demonstrated that it can reduce dementia symptoms by up to 35 percent over an 18-month period. However, the drug is associated with amyloid-related imaging abnormalities (ARIA), which have resulted in the deaths of three trial participants. Notably, two of these individuals carried a gene variant that increases the risk of Alzheimer’s.

The EMA’s updated recommendation permits the use of Kisunla for patients with at most one copy of the gene variant, but only within a controlled access program led by medical teams trained to identify and treat ARIA. Patients will also begin treatment at a lower dose to mitigate risks. The EMA noted that with these safeguards, the advisory group believes Kisunla’s benefits are substantial for both non-carriers and individuals with a single copy of the gene variant.

Implications for Patients and Future Approval

While the EMA has made its recommendation, the final decision rests with the European Commission, which typically aligns with the EMA’s evaluations. Eli Lilly had urged the EMA to reconsider its initial stance, emphasizing that ARIA is often temporary and does not manifest symptoms in most patients.

The initial decision had drawn criticism from Alzheimer advocacy groups. Alzheimer Europe stated that while patient safety remains critical, implementing strict prescribing rules and safety monitoring could enable access to Kisunla for dementia patients while safeguarding against adverse effects.

Additionally, the EMA previously approved another Alzheimer’s drug, Leqembi, which presents similar risks associated with the gene variant. After initially declining approval, the EMA recommended Leqembi for individuals with only one or no copies of the gene, marking it as the first treatment of its kind authorized in the EU.

The Commission is expected to announce its final decision regarding Kisunla in the coming months, potentially offering new hope to patients facing the challenges of early-stage Alzheimer’s disease.