ABOVE: © ISTOCK.COM, OLIVIER LE MOAL
In the face of criticism about Biogen’s recently greenlighted Alzheimer’s therapy and a call for a federal investigation into its approval, company executive Al Sandrock published an open letter last week (July 22) to correct “misinformation” about the drug and the regulatory process it underwent, STAT reports.
“It is normal for scientists and clinicians to discuss data from experiments and clinical trials, to debate, and to disagree, on the interpretation of data,” Sandrock wrote. “Recently, however, there has been a turn outside the boundaries of legitimate scientific deliberation.” The data on aducanumab are “complex,” and the drug’s path to market was not “conventional,” he notes. “But the road to innovation is rarely straightforward, and Aduhelm is not an exception.”
The US Food and Drug Administration (FDA) approved Biogen’s monoclonal antibody aducanumab (Aduhelm) on June 7 for early stage Alzheimer’s disease—the first new therapy approved ...
