WILL BENEFIT THE DEVELOPMENT OF OTHER DEMENTIA DRUGS GREATLY
The LSP Dementia Fund's view on the recent FDA approval
Amsterdam, The Netherlands, June 8, 2021 – Yesterday the U.S. FDA (Food and Drug Administration) announced the approval of Aducanumab (Biogen, BIIB) for the treatment of Alzheimer’s disease, using the accelerated approval pathway. This decision stresses the importance of Alzheimer’s disease as a life-threatening illness. Aducanumab, a monoclonal antibody, invented at the University of Zurich and further developed by Biogen, is the first new Alzheimer’s treatment in more than two decades.
Aducanumab in the highest dose produces unparalleled reduction of amyloid plaques, generally recognized as the cause of Alzheimer’s, and most likely also reduces oligomer formation. This effect has recently also been seen using similar antibodies such as Donanemab (Lilly) and BAN2401 (Eisai), which signifies a truly disease modifying effect.
The discussion among clinicians and FDA advisors centered around the relatively small clinical effect the trials have shown; only one of the two phase 3 clinical studies showed a measurable effect. This may be due to the relatively short duration of treatment and the insensitivity of the outcome measures used. To consider an analogy with oncology: when a treatment makes a tumor significantly smaller, but the investigator has difficulty noticing it clinically yet, still this treatment would definitely be approved.
Dementia is the greatest healthcare challenge of our time. A staggering 50 million patients suffer from dementia worldwide and it is predicted that this number will triple to more than 150 million before the year 2050. The burden to our healthcare system is equally large; global costs are currently estimated to amount to over USD 800 billion - or 1.1% of global GDP - and will rise exponentially if no treatment is found.
LSP has recently launched a fund dedicated to dementia, the first of its kind in the world, under the leadership of Professor Philip Scheltens, director of the Alzheimer Centre Amsterdam. Philip and LSP have brought together a very experienced team in order to foster and boost drug development in the global fight against Alzheimer’s disease and other dementias.
‘’We feel that this positive FDA decision will benefit the field greatly and has set a bar against which other treatments can be measured’’ says Philip Scheltens. “Patients, researchers, companies, and investors alike will be relieved to see that it is possible to register a drug for Alzheimer’s disease. Aducanumab is not the end, it is only the beginning. We will need to develop many more strategies to really treat the disease, but it must start somewhere. LSP and the LSP Dementia Fund team are dedicated to making this happen’’.