U.S. biotech company Biogen, which commercialized a new treatment for Alzheimer's disease in collaboration with Japanese pharmaceutical company Eisai, is aiming to launch a subcutaneous injection form of Leqembi (ingredient name: lecanemab).
The subcutaneous injection form significantly reduces the administration time from about 1 hour for the existing intravenous injection to around 30 seconds. Self-administration is also possible, increasing the convenience and accessibility of dosing for healthcare professionals and patients and potentially contributing to increased sales.
Chris Viehbacher, Biogen's CEO, noted on the 14th (local time) at the world's largest pharmaceutical and biotech investment event, the 43rd JP Morgan Healthcare Conference held in San Francisco, that "the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the once-weekly subcutaneous maintenance dosing of Leqembi," expressing optimism about the approval.
According to Biogen, the FDA accepted the BLA from Biogen and Eisai the previous day and set the decision date for the approval of the Leqembi subcutaneous injection form for August 31.
If approved, Leqembi could become the only Alzheimer's treatment that can be self-administered at home using an autoinjector. Currently, Leqembi is administered through intravenous injection over about one hour every two weeks.
Leqembi, jointly developed by Biogen and Eisai, is the first antibody treatment to remove the abnormal buildup of amyloid beta protein, a cause of Alzheimer’s disease. Following the FDA's accelerated approval in January 2023, it received formal approval in July of the same year, rapidly gaining authorization in the U.S., Japan, and South Korea. It was launched in South Korea in November of last year. Since it targets amyloid beta protein aggregates before they form clumps, it can only be used for patients in the early stages of mild cognitive impairment or early Alzheimer's disease. It is known that 70% of all dementia cases are caused by Alzheimer's disease.
CEO Viehbacher also mentioned the competition with U.S. pharmaceutical company Eli Lilly, which launched an early Alzheimer’s treatment targeting the same amyloid beta called Kisunla (ingredient name: donanemab). Kisunla is expected to compete with Leqembi, obtaining FDA approval in July 2024.
In a conversation with JP Morgan analysts, he said, "The company is prepared for competition," while noting that "of course, we have Eli Lilly's substantial financial power in mind and do not want to underestimate our competitors." According to him, Kisunla has secured about 30% of new Alzheimer’s patients since receiving FDA approval. He projected that "for the next decade, Leqembi and Kisunla will dominate the field of Alzheimer's treatment."
Biogen also expressed confidence in its candidate substances for dementia treatment. The company is developing a treatment targeting tau protein, also cited as a cause of Alzheimer's disease, alongside amyloid beta. So far, no tau-targeting Alzheimer’s treatment has received FDA approval.
During an interview with Reuters at the event, CEO Viehbacher emphasized, "Biogen has gained confidence based on the strengths of its current pipeline, which includes Leqembi and the experimental drug BIIB080, targeting 'tau,' another protein found in the brains of Alzheimer’s patients." He stated that "Biogen is increasingly focusing on Alzheimer's treatment," adding, "We expect that revenues from new product launches will exceed current performance by 2028," and that "there is no urgent need for further acquisitions for additional business development at this time."
Biogen reported that its revenue for the third quarter of 2024, announced at the end of October last year, declined by about 3% compared to the same period the previous year, recording $2.47 billion (approximately 3.6086 trillion won). Leqembi's revenue in the third quarter of last year was $67 million (approximately 979 million won). According to the company, Leqembi's annual revenue for 2023 was only $10 million (approximately 14.6 billion won), but it has since continued to show a steady increase in sales.