Following US FDA approval for Japan-based Eisai Co., Ltd (TYO: 4523) and Biogen Inc’s (NASDAQ: BIIB) novel Alzheimer’s therapy Leqembi (lecanemab), Eisai CEO Haruo Naito gave an interview with Nikkei setting out his ambitions for the drug. According to Naito, the US market eligible to use Leqembi annually currently stands at around 100,000, while globally, once markets such as India and China are added by 2030, that number is put at 2.5 million.
FDA Approval and Clinical Data
The US FDA issued a fast-track approval for Leqembi in 100 mg/mL injection form on Friday last week based on Phase IIb data only, indicated as a treatment for mild cognitive impairment or dementia. Recently published Phase III data show that lecanemab can produce a 27% slowdown in cognitive decline in early-stage Alzheimer’s patients. The drug’s recommended dosage is 10 mg/kg administered intravenously once every two weeks.
Market and Pricing
Leqembi is Eisai/Biogen’s second major Alzheimer’s antibody to win approval in the US in a matter of months, following the also amyloid beta-targeted Aduhelm (aducanumab) in June 2021. As with Aduhelm, the approval is not without controversy. Leqembi use is also associated with significant side effects including amyloid-related imaging abnormalities (ARIAs) – swelling or bleeding in the brain – affecting over 20% of patients in one study compared to just over 9% in placebo.
Eisai/Biogen expects Leqembi to be made available to US patients by January 23, priced at USD 26,500 for one year of treatment, or around half the price of Aduhelm. Notably, the drug was filed for approval in China by Eisai in late December 2022, while filings in the EU and Japan have yet to be formally made.
Future Outlook
The approval of Leqembi by the FDA and Eisai’s ambitious plans for global expansion highlight the ongoing efforts to address the significant unmet needs in Alzheimer’s disease treatment. With demonstrated efficacy in slowing cognitive decline and a more accessible pricing strategy, Leqembi is poised to make a meaningful impact on patient outcomes. Eisai’s strategic focus on expanding into key markets such as China and India underscores its commitment to making this innovative therapy available to patients worldwide.-Fineline Info & Tech
