What is being called the most shocking Biotech news of 2019, Biogen (a biotechnology company) announced this week that it plans to submit an application to the U.S. Food and Drug Administration (FDA) to pursue regulatory approval for the drug Aducanumab.
In March of 2019, Biogen terminated its Phase III trials of Aducanumab after disappointing results. This drug was developed to target beta-amyloid plaques in Alzheimer’s disease, which are thought to be at least one contributor to the disease.
Originally, there were two clinical studies, both with patients who were confirmed to have beta-amyloid plaques and at least mild cognitive decline. These two studies were called EMERGE and ENGAGE and they were conducted over the same time period. The EMERGE study showed statistically significant changes over placebo, while the ENGAGE study results were negative. The participants in the ENGAGE study performed worse on the highest dose of Aducanumab than those on the placebo.
The decision of Biogen to now move forward with their FDA application is based on a new analysis of a larger data set from the Phase III clinical studies. Some believe that the reason the ENGAGE study had negative results was that fewer patients received a high dose of the drug and there were fewer participants. Due to the inconsistencies in the data, it is possible that the FDA will require an additional study.
The important thing to remember is that everyone got worse over the course of the trial. The only hopeful aspect is that the rate of decline when taking the drug was reduced by 23% compared to those on the placebo. Aducanumab did not halt or reverse the disease. It merely slowed the progression. While this drug, if approved, may provide some hope for amyloid plaque removal, broad research must continue into areas that will hopefully stop, reverse and prevent the disease.