{"id":33464,"date":"2023-07-10T00:09:53","date_gmt":"2023-07-10T04:09:53","guid":{"rendered":"https:\/\/ifintechworld.com\/news\/biogen-and-alzheimers-disease-too-early-to-celebrate-nasdaqbiib\/"},"modified":"2023-07-10T00:09:55","modified_gmt":"2023-07-10T04:09:55","slug":"biogen-and-alzheimers-disease-too-early-to-celebrate-nasdaqbiib","status":"publish","type":"post","link":"https:\/\/ifintechworld.com\/?p=33464","title":{"rendered":"Biogen And Alzheimer’s Disease: Too Early To Celebrate (NASDAQ:BIIB)"},"content":{"rendered":"
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On July 6, 2023, the Food and Drug Administration granted full approval to Biogen (NASDAQ:BIIB<\/span>) and Eisai\u2019s (OTCPK:ESALF, OTCPK:ESAIY) anti-amyloid antibody drug Leqembi. For some physicians, advocates of the amyloid hypothesis of Alzheimer\u2019s disease, Alzheimer\u2019s organizations, investors, caregivers, and loved ones it was a day to celebrate. But others remain deeply skeptical about the efficacy and safety of the drug.<\/span><\/p>\n

The initial Wall Street reaction to the news was lukewarm at best. Biogen\u2019s stock dropped almost ten points or roughly 3.5%. Leqembi\u2019s full approval has been expected for quite some time. Some analysts see this as a temporary blip that will right itself over the long term once production is ramped up, more infusion centers are opened up, and a non-infusion method of administering the drug is developed. However, the strongly worded FDA warning label<\/span> regarding the potential for brain swelling (edema) and brain bleeds (hemorrhaging) is something that is likely to remain. And later in this article, I will present a series of scenarios that could dampen Biogen\u2019s profits and cause some investors to sell the stock.<\/span><\/p>\n

Before doing so, I want to briefly return to and refine my observations from a previous article regarding the impact of Leqembi on ApoE4 carriers and non-carriers. The rate of decline between carriers and non-carriers begins to diverge around a CDR-SB score of about 3.2 which is both indicative of very mild Alzheimer’s disease and quite close to the mean baseline for participants in lecanemab’s (now Leqembi) phase 3 clinical trial.<\/p>\n

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Progression rates of ApoE4 carriers versus non-carriers (Original Research Radiology)<\/span><\/p>\n<\/figcaption><\/figure>\n<\/p>\n

At 18 months from a baseline of 3.2, non-carriers would decline to about 4.2 points whereas carriers would decline to about 5.5 points. Biogen and Eisai though combined carriers and non-carriers into one placebo group. In essence, they landed upon a decline at 18 months (4.83 points) that fits between the blue non-carrier line and the green non-carrier line. Further separating between the decline in those with two copies of the ApoE4 gene and those with one copy of the gene becomes somewhat more complicated. Carriers with two copies of the gene progress somewhat more rapidly than those with one copy of the gene (study). Anti-amyloid drugs may have at least a slightly greater impact on those with two copies of the gene than on those with one copy of the gene (clinical trial). Taking into account the variables discussed above, it is possible to provide a more accurate estimate of the impact of Leqembi on ApoE4 homozygotes (two copies of the gene), ApoE4 heterozygotes (one copy of the gene), and non-carriers than that provided by Biogen and Eisai.<\/p>\n

Biogen and Eisai\u2019s Numbers<\/p>\n