Shares of Eli Lilly (LLY), a pick for my Jubak Pick’s Portfolio in a post yesterday, are up 8.89% today as of noon New York time, September 28, on news that an experimental Alzheimer’s drug from Biogen (BIIB) and Japan’s Eisai(ESALY) slowed cognitive and functional decline by 27 percent in a clinical trial. Today shares of Biogen are up 38.07% and shares of Eisai are up 62.6% on the news.
Why the pop in Lilly? As I explained in my post yesterday, Lilly has its own Alzheimer’s drug in development and positive results out of Biogen/Eisai are thought to be a positive for that drug too.
Eisai and Biogen said the slowing of deterioration, compared with a placebo, was “highly statistically significant.” They said the drug, called lecanemab, had met the primary and secondary goals of the 18-month late-stage study. The trial results have not undergone peer review.
The trials showed a 27% slowing of mental deterioration. That seems modest, but it is, potentially, a huge breakthrough in Alzheimer’s treatment. That disease has been extremely resistant to analysis. Last year another drug, marketed as Aduhelm, sponsored by the two companies, essentially died in the marketplace after the trials were shut down early and as analysis of the data raised a score of questions about the drug’s efficacy. Aduhelm was approved by the Food and Drug Administration, but Medicare refused to cover it broadly.
Like Aduhelm, the new drug lecanemab reduces abnormal clumps of beta-amyloid, a hallmark of Alzheimer’s. But unlike Aduhelm, the trial results look straightforward. The lecanemab trial, called Clarity AD, was completed according to protocol.
Biogen and Eisai have already applied to the FDA for accelerated approval for lecanemab, based on earlier-stage data. The FDA’s deadline for a decision is January 6. The firms said the FDA has agreed that the results of the Clarity AD trial can serve as the confirmatory study to verify the clinical benefit of lecanemab.
But Eisai officials said Tuesday they will also seek full FDA approval for the drug after they get the expedited approval. Full approval would make it much more likely that the treatment would be covered by Medicare and other insurers.
Eisai said it will present the full results of the study in late November at an Alzheimer’s conference in San Francisco.