Biogen pushed aducanumab past a 10-1 FDA panel rejection — three panelists resigned

Aducanumab (Aduhelm) was Biogen's monoclonal antibody for Alzheimer's disease targeting amyloid beta plaques. Two identical Phase III trials — EMERGE and ENGAGE — produced contradictory results: EMERGE showed a 22% reduction in cognitive decline at the high dose, while ENGAGE showed a non-significant 2% reduction. Despite this, Biogen submitted for FDA approval.

In November 2020, an FDA advisory committee voted 10-1 against approval, citing insufficient evidence and "red flags" in the data analysis. The FDA approved aducanumab anyway in June 2021 — its first Alzheimer's drug approval in 18 years. Three of the panel's 11 experts resigned in protest, with one calling it "probably the worst drug approval decision in recent US history." The approval came with a $56,000-per-year price tag.

Sales were catastrophic. By September 2021, only about 100 people had received the drug — Wall Street had expected 10,000. The Kaiser Family Foundation estimated the cost to Medicare could be $29 billion in the first year alone, directly contributing to a 14% increase in Medicare Part B premiums for 2022. In December 2021, the European Medicines Agency rejected the drug outright. Biogen halved the price to $28,200, but it was too late. In January 2024, Biogen announced it was terminating the post-marketing study and abandoning commercial development of Aduhelm.

Biogen spent $3.3B marketing a drug that only 100 patients bought, after winning approval despite a 10-1 panel rejection and three resignations.

Biogen pushed approval despite two identical Phase III trials contradicting each other — one showing 22% benefit, the other 2%. The FDA panel voted 10-1 against, but the agency approved it anyway.

Biogen spent $3.3B on sales and marketing — twice its development spend — for a drug that 100 patients bought. The $56,000/year price triggered a $29B projected Medicare cost and a 14% premium hike.

Three FDA panelists resigned in protest, the EMA rejected the drug, and a House investigation found the FDA broke its own protocols and held unreported meetings with Biogen.

An FDA approval is not a market. Biogen spent $3.3B marketing a drug that 100 patients bought — the real customers did not agree with the regulators.