Another Alzheimer’s Drug a Huge Flop*
Meanwhile, the FDA won’t stop trying to eliminate brain health supplements. We think they want to clear the field for when they finally do approve a drug.
Two years ago we reported that Eli Lilly had a potential blockbuster drug for Alzheimer’s in the third and final phase of FDA trials. If it won approval, it was expected to bring in $7.6 billion in sales by 2024.
The results are in, and it’s back to the drawing board for Eli Lilly. The drug showed no statistically significant benefits in halting cognitive decline.
In the meantime—clearly intending to approve this new Alzheimer’s drug—the FDA launched an attack against key brain health supplements picamilon and vinpocetine. There was precedent for such a move—the FDA did the same thing to tryptophan before the first SSRI antidepressant drugs came out. It’s a key move in the crony playbook.
The agency went one step further in its attack on vinpocetine, reaching a “tentative conclusion” that this important supplement does not meet the definition of a dietary ingredient—despite the fact that a new dietary ingredient (NDI) notification for vinpocetine was already accepted by the FDA. Additionally, the agency is claiming that vinpocetine is already being investigated as a new drug—which means it could no longer be sold as a supplement.
Eli Lilly’s drug must have failed quite spectacularly not to get FDA approval, considering the legwork the agency had already gone through to clear the decks of natural competitors. This goes to show the lengths to which the FDA will go to protect its Big Pharma clients.