The situation is escalating: While the number of Alzheimer’s patients in Germany and worldwide is increasing dramatically, a pharmacological breakthrough still seems to be far away. New drug candidates keep emerging that make it to the final phase of clinical approval but fail due to insufficient efficacy – and so far, not a single one has succeeded in halting mental decline.
That makes the news, which is currently running through the press, all the more worthy of attention: The new anti-dementia drug Lecanemab is said to slow down mental decline in patients by 27 percent, and the manufacturers Biogen and Eisai are currently seeking rapid market approval.
But what is really behind all this and what is the current situation on the Alzheimer’s drug market?
Immunotherapeutics, in particular antibodies against the Alzheimer’s-specific amyloid-ß (Aß) deposits, recognizable by the suffix “-mab”, are currently on the rise. However, compounds called solanezumab (Eli Lilly) and bapineuzumab (Janssen and Pfizer) failed several years ago due to lack of clinical efficacy signals. In 2022, crenezumab and gantenerumab, two candidates from Swiss pharmaceutical company Roche, also failed to show efficacy against the fatal brain disease, and thus they too dropped out of the clinical approval process. Even the most promising drug candidate to date, Aducanumab (Biogen/Eisai), which made it to approval in 2021, albeit in a highly controversial approval process and only in the U.S., is questionable in terms of its efficacy. In Europe, its approval was rejected by the European Medicines Agency (EMA) due to “an unproven efficacy and possible serious side effects of the drug.”
The antibody Lecanumab now seems to be the new hope: the results of the clinical registration trial called Clarity-AD have not yet been published in the scientific press but are expected to be presented at the Clinical Trials on Alzheimers Congress at the end of 2022.