’FDA Accepts Eisai’s sBLA for LEQEMBI IV Maintenance Dosing Amidst Biogen’s Market Challenges’
TOKYO and CAMBRIDGE, Mass. June 9, 2024’ - Eisai Co. Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, Eisai) and Biogen Inc. (Nasdaq: BIIB, Corporate Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher) today announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Supplemental Biologics License Application (sBLA) for LEQEMBI (lecanemab-irmb) intravenous (IV) maintenance dosing. The Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025. This acceptance marks a pivotal advancement in the treatment of Alzheimer’s disease (AD) for patients in the early stages, specifically those with mild cognitive impairment or mild dementia.
LEQEMBI, having established its efficacy for early AD, represents a significant step forward in addressing the therapeutic needs of patients who have long awaited more effective maintenance treatment options. The approval for sBLA reflects the impressive strides made by Eisai in the development of LEQEMBI, aimed at slowing the progression of Alzheimer’s disease.
In the broader context of the pharmaceutical industry, Biogen Inc. has encountered notable financial fluctuations in the first quarter of 2024. The company reported a year-on-year revenue decrease of 7%, which surpassed the overall decline of its competitors, recorded at 3.43% over the same period. Despite these challenges, Biogen Inc. demonstrated robust profitability with a net margin of 17.18%, outperforming its industry peers. In contrast, the industry at large has experienced a significant contraction in net income, down by 86.03%.
Moreover, during this period, Biogen Inc.’s net income grew by 1.5% year-on-year, a stark improvement compared to its competitors who have mostly seen a decrease in earnings. However, Biogen Inc.’s market share fell to 2.3% in Q1 2024 from 2.57% in Q4 2023, resulting in a market share of 2.46% over the past 12 months.
The FDA’s acceptance of Eisai’s sBLA for LEQEMBI provides a hopeful outlook not only for patients with early Alzheimer’s disease but also for Biogen Inc. potentially reinvigorating their market position. This development underscores the ongoing commitment and innovation in the biopharmaceutical sector aimed at combating one of the most challenging neurodegenerative diseases.
As Eisai and Biogen look toward the upcoming PDUFA action date, the industry will keenly observe how LEQEMBI’s intravenous maintenance dosing could redefine treatment paradigms in early Alzheimer’s disease and potentially impact Biogen Inc.’s financial trajectory in a competitive market landscape.
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