Alzheimer’s disease devastates millions of families each year. Alzheimer’s, which is one form of dementia, has no cure and is the sixth leading cause of death in the U.S. There are drugs to help curb symptoms, but nothing to stop the disease.
The drugmaker Biogen has been in the news recently regarding its drug aducanumab. Aducanumab targets beta-amyloid, a type of compound in the brain that is thought to play a major role in the disease. In its Phase 3 EMERGE study with the drug, aducanumab had a statistically significant lowering in clinical decline compared with placebo, according to information released in October 2019. (Phase 3 studies are the last set of studies done before a company decides to file for drug approval with the U.S. Food & Drug Administration.) In a subset of patients using a higher dose of aducanumab, there were significant positive effects on
- activities of daily living, such as money management and traveling outside the home.
This is all according to the Biogen website.
An interesting wrinkle in the story of aducanumab is that in March 2019, the drugmaker said it was going to halt research with the drug. They said they did this because the drug was not working. This sent Biogen’s stock to rapidly plummet and sent shockwaves among health care and among families affected by Alzheimer’s. That’s because the drug seemed to be a ray of hope in an area that otherwise has shown little promise for a cure. However, researchers worked over the next several months to analyze the data further and found some other ways to look at the numbers—realizing that the drug actually did have a positive effect. Find more information about the company’s research and financial roller-coaster ride in this Bloomberg article.
Based on these results, Biogen is planning to submit a drug application to the U.S. Food and Drug Administration in early 2020 and also continue to speak with regulatory bodies in Europe, Japan, and other parts of the world. For now, however, the drug is not approved in the U.S.
Although it’s not yet clear if the Food and Drug Administration will approve the drug, the results so far from aducanumab offer some hope for family members and friends with loved ones affected by Alzheimer’s disease.
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