Biogen now has data from twice as many patients, from both clinical trials, and executives used those results to justify seeking approval. Some 5.5 million Americans have Alzheimer’s disease, not including those in the very early stages, and there is no effective treatment. Biogen officials contend the additional study data showed a slower cognitive decline in the subgroup of patients who got the highest dose. spokesman said the agency does not comment on investigational drugs or on drug approval applications. When Alzheimer’s specialists see the details in December — better yet, when there is a peer-reviewed published paper — they may not be convinced the drug has meaningful benefits.
Source: New York Times October 22, 2019 20:48 UTC