Biogen Inc. fought back against criticism of the unusual circumstances that led to the U.S. approval of its Alzheimer’s drug Aduhelm, saying in an open letter it has been the subject of “extensive misinformation and misunderstanding.”
Aduhelm, approved in June, is controversial because it hasn’t been shown to slow cognitive decline. Two big tests were stopped early by Biogen and ended up producing contradictory results. But the Food and Drug Administration still gave it an accelerated clearance on the basis of its ability to remove an abnormal protein called amyloid from the brain.
Since then, the approval has been heavily criticized…
