Alzheimer's is characterized by the accumulation and clumping of the proteins amyloid and tau in the brain. The drug Aducanumab dissolves the accumulation of the protein amyloid and reduces its clumping together. This slows down the disease process, in contrast to current medicine that only treat symptoms. Aducanumab is an important first step towards developing medicine and possible combinations of medicine to eventually fight Alzheimer's disease. It is not yet the solution for every patient with Alzheimer's. Only a small group of patients qualify. The FDA approved Aducanumab under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment. The FDA is requiring Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. However, this approval sends an important signal that it is actually possible to do something about the brain damage caused by Alzheimer's.
Amsterdam UMC part of global study
Amsterdam UMC was involved in the investigation into the drug Aducanumab that underlies this FDA decision. In the Brain Research Center, the research center of Alzheimer Center Amsterdam, 34 patients with mild cognitive impairment (MCI) or early-stage Alzheimer's disease were treated with Aducanumab. In total, 3,482 patients worldwide participated in this double-blind, randomized, placebo-controlled dose-ranging studies.
Niels Prins, director of Brain Research Center: "It is a great step forward that the FDA has approved the drug Aducanumab for the US market. For the first time, patients with Alzheimer's can be treated with a drug that inhibits the disease. At the same time, we have to realize that this is not the solution to Alzheimer's. There is still a lot of work to be done in that regard.”
Preparing the Dutch healthcare system
Many patients and people in their environment naturally want to know when the medicine will be on the market in the Netherlands. The FDA's ruling is independent of the authorization to enter the European market. This requires approval from the EMA (European Medicines Agency), which is also currently examining the application. If EMA follows the line of the FDA, important questions are who qualifies for the medicine and how the treatment will be offered in the Netherlands. The Dutch healthcare system will have to be prepared for this. The national ABOARD project that started in April this year is taking the first steps to prepare the healthcare system. More than thirty partners join forces in ABOARD, including the five Dutch Alzheimer's Centers and Alzheimer Nederland. Public and private parties from the entire knowledge chain work together: from universities to healthcare and knowledge institutions, social organizations and companies.
- News item about the verdict of the FDA
- Philip Scheltens and Jetske van der Schaar at Dutch broadcast Op1 (in Dutch)
- Information on how long it takes for the drug to hit the market, website of Alzheimer Nederland (in Dutch)
- Nieuwsuur broadcast about Aducanumab (in Dutch)