European regulators have reinforced their earlier positive assessment of the Alzheimer’s treatment Leqembi, developed jointly by Eisai and Biogen, following a supplementary safety evaluation. This development brings the medication closer to receiving approval from the European Commission.
The European Medicines Agency (EMA) conducted an additional review of recent safety information that emerged after the drug’s initial endorsement in November. After examining the new data, the regulatory committee maintained its supportive stance, choosing not to alter its previous recommendation.
If approved, Leqembi would become available across the European Economic Area’s 30 member states, where approximately 22 million individuals are affected by Alzheimer’s-related cognitive decline and dementia. This advancement represents a significant turnaround for the drug in Europe, particularly considering the EMA’s initial rejection before reversing its decision following an appeal by the
pharmaceutical companies.
Leqembi, along with its competitor Kisunla from Eli Lilly, functions by eliminating amyloid beta, a harmful protein found in the brains of Alzheimer’s patients. While both medications demonstrate modest effectiveness in slowing disease progression, they carry the risk of ARIA (amyloid-related imaging abnormalities), which can manifest as brain swelling or microscopic bleeding.
The occurrence of ARIA-related complications has led healthcare providers to exercise caution when prescribing these medications. This concern was initially reflected in the EMA panel’s decision to reject Leqembi in July of last year, when they determined that the drug’s cognitive benefits did not sufficiently outweigh its potential adverse effects.
In an unusual turn of events, Eisai and Biogen’s appeal proved successful, despite the typically low success rate of such challenges. The committee’s reversal was based on their assessment that ARIA risks varied significantly depending on patients’ genetic profiles. Specifically, individuals with either no copies or a single copy of the ApoE4 gene variant showed lower risk levels, making them suitable candidates for treatment. However, patients carrying two copies of this gene variant, who typically experience earlier disease onset, were deemed to face excessive risks from the treatment.
The path to potential European approval highlights the complex balance between therapeutic benefits and safety considerations in Alzheimer’s treatment. Medical professionals have approached these new
amyloid-clearing drugs with measured optimism, carefully weighing their modest clinical benefits against potential complications.
The success of Leqembi’s appeal process demonstrates the evolving understanding of how genetic factors can influence treatment outcomes and safety profiles. This personalized medicine approach, considering genetic markers like ApoE4 status, represents an important advancement in Alzheimer’s treatment strategy.
The anticipated European Commission decision would mark another milestone in Leqembi’s global availability, following its earlier approvals in other regions. The potential addition of the European market could significantly expand access to this treatment option for Alzheimer’s patients, though careful patient selection based on genetic factors will remain crucial for safe and effective
implementation.
The progression of Leqembi through European regulatory channels reflects the broader challenges and opportunities in developing treatments for neurodegenerative diseases, where the balance between efficacy and safety requires careful consideration and may vary among different patient populations.