Eisai says Leqembi ramp-up taking “slightly more time” in the US
07 Mar 2024
Drug ApprovalBiosimilar
Reflecting comments made earlier this year from both Eisai and partner Biogen, the Japanese drugmaker conceded Thursday that the launch of Alzheimer’s disease therapy Leqembi (lecanemab) is “steadily progressing” in the US, rather than hitting the heights it previously hoped for.
"In the [US], in comparison to what we have expected, it may be taking slightly more time," Eisai CEO Haruo Naito said, although he added “we are confident that we are on a good trajectory."
Eisai reported last month that sales of Leqembi reached around $7 million in the third quarter of fiscal year 2023, with around 2000 patients undergoing treatment with the anti-amyloid antibody at that time. The Japanese drugmaker previously targeted the treatment of 10,000 people by the end of fiscal year 2023.
Shortly after Eisai’s release of the numbers, Biogen CEO Chris Viehbacher highlighted more up-to-date figures suggesting that about 3800 patients were recorded on patient registries as taking Leqembi. At the time, Viehbacher said “there's plenty of demand from patients… It really is a question of the system being able to accommodate this new flow of patients.”
Behind target for established pathways
Naito disclosed Thursday that, so far, 90% of the 80 integrated delivery networks (IDNs) it is targeting to have an established pathway in place by the end of the current fiscal year currently do so. However, these targets fall for other treatment pathways, with 81% of neurologists having one and 64% of community practices.
The numbers support findings from a recent physician's poll conducted by FirstWord, which revealed that 20% of community providers find the necessary processes needed to identify eligible patients for Leqembi as “extremely challenging.” In contrast, none of the physicians at academic medical centres indicated that the requirements were any more than “moderately challenging.” Further, just over 40% of all neurologists surveyed indicated that it takes at least 4 weeks from their broaching the subject of treatment with Leqembi to a given patient being administered the drug.
Sales ambitions of $10.7 billion
Eisai also revealed that it expects sales of Leqembi to exceed JPY 1.6 trillion ($10.7 billion) in fiscal year 2032, comprising use in both preclinical and early Alzheimer’s disease. Morgan Stanley analysts, who peg sales in fiscal year 2032 of up to $12.9 billion, noted that the company aims to have FDA approval for the subcutaneous formulation of Leqembi and maintenance treatment by March 2025.
Meanwhile, according to Naito, the debut of Leqembi in Japan has progressed smoothly, while the company is ramping up production ahead of a planned July launch in China. The executive noted that the Chinese system for diagnosis and treatment of Alzheimer's disease is unique and could serve as a model for expansion in India, as well as other markets in Asia and Africa.
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