Eisai, a pharmaceutical company, has encountered significant challenges in introducing its Alzheimer’s drug, Leqembi, to the European market following a negative assessment by the European Medicines Agency (EMA). The EMA’s Committee for Medicinal Products for Human Use (CHMP) advised against granting marketing authorization in Europe, citing that the drug’s benefits do not sufficiently outweigh its risks. This decision mainly concerns the potential side effects linked to amyloid-related imaging abnormalities (ARIA), which include brain swelling and bleeding.
Leqembi, an intravenous drug administered bi-weekly, targets the amyloid protein plaques, a typical indicator of Alzheimer’s progression, by binding to the amyloid and reducing its buildup in the brain. Eisai developed the drug in cooperation with Biogen under a neuroscience alliance, with Eisai taking the lead on Leqembi’s development.
Support for the FDA’s approval of Leqembi in the United States was based on clinical trial data where the main endpoint was assessing cognitive impairment via the CDR-SB scale at 18 months. The results demonstrated a smaller average score increase in the treatment group compared to a placebo group, indicating less cognitive decline among those who received the drug. However, the CHMP remained unconvinet by similar data, focusing instead on the risks of serious side effects.
The CHMP’s concerns were amplified by the heightened risk of ARIA in patients with the ApoE4 gene, which is associated with a higher likelihood of developing Alzheimer’s. Specifically, the risk increases in individuals with two copies of the gene. This consideration was influenced by feedback from a scientific advisory group, which included neurologists and Alzheimer’s patients.
ARIA is a recognized risk for drugs in the anti-amyloid antibody class, which also includes other treatments like Aduhelm from the Eisai/Biogen partnership and Kisunla by Eli Lilly. The latter was approved by the FDA but noted for higher ARIA complication rates during clinical trials. Despite these concerns, the drugs carry warnings about these risks on their labels.
The CHMP’s negative stance on Leqembi has also affected financial forecasts, with William Blair analyst Myles Minter indicating potential risks to projected peak sales of $1.33 billion in the European Union by 2035. The United States remains a more significant market, with projected sales of $4.6 billion by the same year. Minter highlighted that only 25% of negative opinions by CHMP are overturned upon re-examination, though he suggested that ongoing global use and adjustments such as reduced dosing frequency might strengthen Eisai’s case for EMA approval.
Despite this setback, the analysts maintain optimism about the future of these drugs in Europe. They anticipate both continued efforts by Eisai to gain EMA approval and potential challenges for Lilly’s Kisunla, though they do not expect these issues to significantly impact the competitive landscape in the EU.
As it stands, Leqembi has been approved by regulatory bodies in other regions including Japan, China, South Korea, Hong Kong, and Israel. Eisai plans to seek a re-examination of the CHMP’s negative opinion, hoping to eventually bring Leqembi to European patients.
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