Friday, November 5, an important gathering of independent experts representing the U.S. Food and drug Administration (FDA) advising on possible approval of the experimental Alzheimer’s drug Aducanumab from the American biotech company Biogen. The experts indicated that they were not convinced by the data from the two large phase 3 studies Emerge and Engage. They advised that the two studies do not provide sufficient evidence for Aducanumab to slow down Alzheimer’s disease.
The FDA may deviate from such advice, but almost always accepts it. The FDA itself is still divided. Director of the neuroscience section, Billy Dunn, said Biogen’s studies were “very convincing,” while an FDA statistician found the results contradictory. The FDA’s final ruling on the admission of Aducanumab to the US market is expected in March 2021.
In order to be able to market the drug in the Netherlands, it will need approval from the EMA (European Medicines Agency) and the Ministry of Health, Welfare and Sport. A step towards this was taken in October with an application to the EMA.
Biogen is currently conducting a Phase 3 follow-up study with Aducanumab, the Embark Study, in patients previously enrolled in the Emerge of Engage studies. This research is also expected to start at Brain Research Center in December 2020.
Dr. Niels Prins, director of Brain Research Center says. “Despite this negative opinion from the expert panel regarding the marketing of Aducanumab, we remain hopeful to find new drugs for Alzheimer’s. In any case, the research showed it is possible to clear up the abnormal protein in the brain with a drug. In some of the patients this also leads to less deterioration. The hypothesis that Alzheimer’s is caused, among other things, by toxic protein accumulations in the brain seems to be correct. ”
BACKGROUND
The research ran from May 2016 to March 2019 at various research centers around the world. At Brain Research Center in Amsterdam 34 patients were treated with Aducanumab. In total, this involves almost 3300 people worldwide.
In March 2020, the study was initially discontinued by Biogen, because, based on a smaller data set, it was expected that it would not achieve the desired effect. Recently, however, Biogen has analyzed a larger data set and according to the pharmaceutical company it did show a positive effect. On the basis of this, it was decided to request permission to market the product.
Relevant links:
https://investors.biogen.com/news-releases/news-release-details/update-fda-advisory-committees-meeting-aducanumab-alzheimers
https://www.sciencemag.org/news/2020/11/biogen-s-alzheimer-s-drug-candidate-takes-beating-fda-advisers
https://www.globenewswire.com/news-release/2020/10/30/2117651/0/en/European-Medicines-Agency-Accepts-Biogen-s-Aducanumab-Marketing-Authorization-Application-for-Alzheimer- s-Disease.html
