Inside ‘Project Onyx’: How Biogen used an FDA back channel to win approval of its polarizing Alzheimer’s drug

It was perhaps the most contentious drug approval in decades, shocking drug company executives, insurance companies, and politicians alike: The Food and Drug Administration, 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.”

But Biogen executives were hardly passive players hoping for FDA approval. In spring 2019, when Aduhelm’s prospects appeared dead, the Cambridge, Mass.-based behemoth mounted a secret campaign, code-named “Project Onyx,” to resurrect the drug and convince the FDA to give it the green light.

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