Posted by Michael Wonder on 29 Jun 2021
Inside ‘Project Onyx’: how Biogen used an FDA back channel to win approval of its polarising Alzheimer’s drug
29 June 2021 - It was perhaps the most contentious drug approval in decades, shocking drug company executives, insurance companies, and politicians alike: the FDA, over the objections of its scientific advisers, backed the first new Alzheimer’s medication since 2003, one that could finally give millions of dementia patients a reason for optimism — and reap billions of dollars for its manufacturer, Biogen.
After the FDA’s approval of the medicine called Aduhelm three weeks ago, the company’s CEO, Michel Vounatsos, proclaimed on Biogen’s website, “I have hoped for years that we would reach a moment like this.”
