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After being approved in the US on January 6 under the brand name Leqembi, Tokyo-based Eisai (which led the co-development with Biogen) has been approved by the European Medicines Agency (announced January 10) and the Japanese Agency for Pharmaceuticals. I submitted a marketing authorization application. Medical Devices Agency (announced January 15).
In Japan, PMDA’s pre-evaluation consultation system, which can be used to shorten the review period for lecanemab, is being used. However, the expected timescale of the process is not given.
In Europe, the process will be watched especially closely as Eisai hopes to succeed where Biogen’s anti-amyloid Alzheimer’s drug Aduhelm failed. Aduhelm application down]cited concerns about the poor association between amyloid-beta reduction and clinical improvement and the occurrence of amyloid-associated imaging abnormalities (ARIA).
Elsewhere, Eisai began submitting data for BLA to China’s National Medicines Administration (NMPA) in December.
Lecanemab is an anti-inflammatory drug for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia (collectively known as early AD), in which amyloid lesions are documented in the brain. Amyloid beta (Aβ) protofibril antibody.
The European EMA and Japanese PMDA submissions are based on the results of the Phase 3 Clarity AD trial and the Phase 2b clinical trial.
In the United States, the drug was approved this month by the US Food and Drug Administration (FDA) under an accelerated approval pathway. Eisai is currently Additional biologics license applications will also be filed for the traditional approval pathway.
Eisai is the global lead in the development and regulatory submission of lecanemab, with both Eisai and Biogen co-commercializing and co-promoting the product, with Eisai having final decision-making authority. .
In the Clarity AD trial, treatment with lecanemab resulted in “highly statistically The decline decreased as early as 6 months and over time at all time points.”
All key secondary endpoints also showed highly statistically significant results. Notably, treatment with lecanemab demonstrated a statistically significant reduction in amyloid plaque burden at all time points starting at 3 months in the amyloid PET study and a statistically significant reduction in activities of daily living in ADCS MCI-ADL3. delayed to
The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combination of cerebral microhemorrhage, cerebral hemorrhage, and superficial siderosis), ARIA-E (edema/pleural effusion), I had a headache and a fall.
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