Expert Society Speaks Out on Alzheimer Treatment Controversy

Donanemab, a monoclonal antibody, has received approval for use in several countries, including the United States and Japan, for the treatment of adults with early symptomatic Alzheimer's disease.

Professor Dr. Jörg B. Schulz from Aachen University Hospital and a spokesperson for the German Society of Neurology (DGN) emphasized that while amyloid antibodies are not a cure for Alzheimer's and can have side effects, they can potentially slow disease progression by over 30% when appropriately prescribed. This delay may offer many newly diagnosed Alzheimer's patients significant additional months of relatively 'healthy' living.

Dr. Schulz pointed out that patients in other therapeutic areas, such as cancer treatment, often accept higher risks associated with medications approved by the European Medicines Agency (EMA) after thorough consultations about the benefits and risks. However, he noted that patients with Alzheimer's currently lack this option. The DGN expressed concern that a generation of individuals with early-stage Alzheimer's could miss out on the potential advantages offered by this treatment due to the EMA's decision.

As the disease progresses, the likelihood of benefiting from Donanemab diminishes, and the risks of side effects may increase. Dr. Schulz acknowledged the significance of the side effects associated with Donanemab but suggested that they could be mitigated by limiting access to patients who do not carry ApoE4 gene copies and implementing rigorous therapy monitoring.

Professor Dr. Peter Berlit, Secretary General of the DGN, echoed these sentiments, expressing regret that the EMA did not approve the medication with specific access restrictions and mandated risk-benefit counseling. He noted that particularly ApoE4-negative patients with low levels of tau deposits could significantly benefit from Donanemab based on clinical trial data, and the EMA could have adjusted the approval accordingly.

In response to the EMA's decision, Eli Lilly, the manufacturer of Donanemab, has announced plans to seek a re-evaluation from the EMA's Committee for Medicinal Products for Human Use. The company maintains confidence in the safety and efficacy of Donanemab and its potential value for patients diagnosed with early symptomatic Alzheimer's disease.