In all my years of writing about the industry, failures in Alzheimer’s clinical trials have been an unfortunate constant. And then, in 2021, the FDA approved Biogen and Eisai’s anti-amyloid antibody Aduhelm. Seemingly good news – but the move was not welcomed by all, with many stakeholders questioning the drug’s efficacy (1). Medicare refused to offer coverage unless patients were taking the drug as part of a clinical trial, and an investigation is ongoing into how the drug was approved in the first place given limited evidence of efficacy. In May 2022, Biogen announced that it would “substantially eliminate the commercial infrastructure” for Aduhelm – and also noted that CEO Michel Vounatsos would step down (2).
Undeterred, the companies are back in the spotlight with another attempt to tackle the intractable. In October 2022, Eisai and Biogen released data from a phase III trial of lecanemab – another anti-amyloid mAb (3). Primary and key secondary endpoints of the trial were met, with data showing that the drug appears to slow cognitive decline by 27 percent in people with mild Alzheimer’s disease. The US Alzheimer’s Association responded (4), “These are the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date.”
Whereas Aduhelm ignited controversy, the industry seems cautiously optimistic about lecanemab. However, the drug has not yet reached the approval stage – brace yourself for more discussions if and when this happens. For now, both companies are enjoying surging stock prices.
Eisai will present more detailed data at the Clinical Trials on Alzheimer’s Congress in late November and plans to publish the results in a peer-reviewed journal. Eisai will also take the lead on the regulatory submission for the drug.
Dealing with the harsh realities of old age is inevitable for most of us – but the onset of Alzheimer’s (and other forms of dementia) in family members or friends is a particularly frightening prospect. I look forward to hearing what experts think of the full results.
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References
- The Medicine Maker, “Addressing the Aduhelm Controversy,” (2022). Available at https://bit.ly/3CQuP3U
- Biogen, “Biogen Reports First Quarter 2022 Results,” (2022). Available at https://bit.ly/3SYTpVX
- Eisai, “Lecanemab Confirmatory Phase 3 Clarity Ad Study Met Primary Endpoint, Showing Highly Statistically Significant Reduction Of Clinical Decline In Large Global Clinical Study Of 1,795 Participants With Early Alzheimer’s Disease,” (2022). Available at https://bit.ly/3TjYmbs
- Alzheimer’s Association, “Alzheimer’s Association Statement on Lecanemab Phase 3 Topline Data Release,” (2022). Available at https://bit.ly/3yE9Grf
