European Medicines Agency Recommends Lecanemab for Alzheimer's Treatment
The European Medicines Agency (EMA) has made headlines this Thursday by recommending the approval of lecanemab, a potential breakthrough drug for Alzheimer’s disease, through an expert committee. This recommendation marks a significant shift in the EMA's stance on the medication, which is among the first in decades to demonstrate tangible effects in combating Alzheimer’s cognitive decline.
Lecanemab, marketed under the brand name Leqembi, was initially met with skepticism due to its associated side effects and high price tag, which exceeds €20,000 per year for each patient. Nevertheless, the Committee for Human Medicinal Products advised that the drug should be prescribed to specific patients—namely, those who do not carry two copies of the APOE4 gene. This genetic variant has been linked to heightened risks of side effects, including inflammation and hemorrhages, which are notable concerns with lecanemab.
The recommendation from the committee follows a substantial clinical trial that involved 1,700 participants suffering from Alzheimer's across multiple countries, including Spain. This trial revealed that lecanemab could delay the progression of the disease by 27%. However, the trial also highlighted the potential dangers of the drug, with 12% of participants experiencing brain inflammation and complications leading to the deaths of two individuals due to hemorrhages.
The development comes at a time when the global medical community is eagerly searching for effective Alzheimer’s treatments, with the prevalence of this debilitating disease growing. Notably, while lecanemab has gained interest in various nations, it is currently approved for use in the United States, China, Japan, South Korea, the United Arab Emirates, and the United Kingdom. Despite this approval, the UK publicly funds for the drug was denied, as authorities deemed its effectiveness insufficient to justify the steep cost.
Experts note that the benefits of lecanemab may only apply to about 5% of Alzheimer’s patients in Spain, emphasizing the necessity for treatment to begin at very early disease stages. As the EMA continues its deliberation post-recommendation, the medical community and families affected by Alzheimer’s will be watching closely to see if this drug's approval finally offers new hope in the fight against this challenging disease.
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