A month after Eisai reported positive, topline phase 3 data of its Alzheimer’s treatment lecanemab, STAT News is out with a new bombshell report that gut-checks the drug’s hype.
The health and science news outlet reported Friday that one of the trial investigators flagged the death of a participating patient following bleeding in the brain and concluded it may have been down to the drug.
Citing a suspect adverse events report it had obtained, STAT reported that Eisai acknowledged “at least a reasonable possibility lecanemab may have contributed to the” hemorrhage but ultimately concluded that other factors made it difficult to nail down. The patient developed the condition while enrolled in the open-label extension of the phase 3 trial, according to STAT, and because the phase 3 trial remains blinded, it’s not known whether they previously received lecanemab or placebo.
Eisai pointed to other health factors impacting the patient, including a heart attack and mini stroke-like events. The company also noted that following the heart attack, doctors prescribed the patient an additional blood thinner even after the bleed was discovered.
Nonetheless, STAT says Eisai directed its data and safety monitoring board to check for whether anticoagulants increased the risk of severe side effects. The board found that in fact, yes, a higher share of treated patients on blood thinners did report severe bleeds compared to those not on blood thinners, but the board concluded that this remained a relatively low-risk. The board ultimately did not recommend against including patients on blood thinners, according to STAT.
In a statement to Fierce Biotech, Eisai acknowledged the death, saying, “all the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall or from any specific cause.” The company also said that information includes a review of all amyloid-related imaging abnormalities (ARIA) safety data. In Eisai’s initial data release, the company reported that the symptomatic rate of ARIA-E was 2.8% compared to 0.0% for the lecanamab and placebo groups, respectively, while the symptomatic rate of ARIA-H was 0.7% and 0.2%.
Eisai sent shockwaves through the pharma world in late September when it posted positive topline phase 3 data of lecanemab, showing a 27% reduction in clinical decline among patients with early Alzheimer’s disease. It was arguably the most consequential clinical Alzheimer’s data to date and provided significant validation to the hypothesis that Alzheimer’s progression could slow if you removed amyloid plaque buildup in the brain.
The company is currently pushing lecanemab through the FDA’s accelerated approval pathway with regulators expected to rule by early January. It then plans to submit full approval filings at the FDA and other global regulators by the end of the first quarter of 2023.
Eisai could have a major blockbuster on its hands though it will heed the lesson learned by its former partner Biogen if it is going to bring in the big bucks. Biogen last year nabbed an historic FDA approval for its Alzheimer's drug Aduhelm, which works in a similar way to Eisai's drug, but the promised blockbuster sales never came after it became a major commercial flop amid ongoing safety concerns, deep questions over its efficacy and the decision not to have the drug funded by Medicare.