The aim of the study with 1,795 participants who were in an early stage of the disease was thus achieved. The companies are already planning the application for approval.
The study compared with a placebo, i.e. the comparison group received a drug that did not contain any active ingredient. However, the tests also showed side effects of lecanemab such as brain swelling and bleeding, although severe cases were rare.
For Biogen, the research results could be an important milestone after the fuss about its Alzheimer’s drug Aduhelm. The US drug regulator FDA approved the drug in the summer of 2021, although the benefit was not clearly proven. As a result, health insurance companies resisted accepting the very high costs. This had repercussions for Biogen, the group launched an austerity program and announced in May that it would be looking for a successor for company director Michel Vounatsos.
Meanwhile, the new drug lecanemab is already being examined by the US authorities as part of an accelerated approval process. Biogen and Eisai now aim to apply for full US approval by the end of March next year. This should also happen simultaneously in Europe and Japan.
Lecanemab cannot cure Alzheimer’s either. Rather, the data indicate that the progression of the disease is being slowed down. The drug does not restore cognitive abilities, nor does it completely stop their loss. David Knopman, clinical neurologist at the Mayo Clinic in Rochester, Minnesota, also told Bloomberg news agency that the delay was ultimately minor. “We can only hope that the benefits are permanent and could grow over time. Those long-term properties are not foreseeable at this point.” The Alzheimer’s Association welcomed the results.