The Alzheimer’s treatment Leqembi has received approval from European regulators following an initial rejection by an advisory committee last summer. This infused treatment, developed by Japanese pharmaceutical company Eisai in collaboration with Biogen, is now sanctioned for use in patients at the early stages of this debilitating disease. The authorization extends to all 27 European Union member countries, along with Norway, Iceland, and Liechtenstein, as announced by the drugmakers on Tuesday.
Previously, the European Committee for Medicinal Products for Human Use recommended against marketing approval for Leqembi in July due to concerns about potential side effects, including brain bleeding and swelling, which can occasionally pose serious risks. However, after Eisai requested a reconsideration, the committee reversed its position and recommended approval in November.
Leqembi functions by targeting and clearing a sticky brain plaque linked to Alzheimer’s disease. A significant study demonstrated that the drug decelerated the decline of memory and cognitive abilities by several months compared to a placebo. The European approval specifies its use for patients with the brain plaque and those with one or no copies of a certain gene, which reduces the likelihood of side effects.
Analysts, including Phil Nadeau from TD Cowen, have highlighted the European approval as a validation of Leqembi’s favorable risk-benefit profile. However, he noted that the drug’s introduction in Europe might proceed gradually over several years. Eisai developed Leqembi and shares marketing efforts with Biogen, headquartered in Cambridge, Massachusetts.
Leqembi and another treatment, Kisunla by Eli Lilly and Co., are the first to convincingly demonstrate a delay in cognitive decline for Alzheimer’s patients. Both have received approval from U.S. regulators. However, the European committee recently decided against approving Kisunla due to similar side effect concerns. Eli Lilly, based in Indianapolis, intends to pursue further discussions regarding their drug’s approval through a decision reexamination process.
In the wake of these developments, Biogen’s shares experienced a modest increase, climbing 25 cents to $117.23 during midday trading on Wednesday, despite broader market declines.
The Impact on Daily Life
The approval of Leqembi in Europe represents a significant step forward in the treatment of Alzheimer’s disease, offering hope to many individuals and families affected by this devastating condition. With this new treatment option, patients in the early stages of Alzheimer’s can potentially experience a slower progression of symptoms, thereby maintaining cognitive function for a longer period. This could translate into an improved quality of life for both patients and their caregivers.
On a broader scale, the gradual introduction of Leqembi across Europe may stimulate advancements in Alzheimer’s research and increase investment in therapeutic development. This could lead to further innovations in treatment options, potentially benefiting a wider range of patients. Furthermore, the approval may encourage healthcare systems across Europe to enhance their capabilities in diagnosing and managing Alzheimer’s disease, ultimately improving patient outcomes and care standards.
