Eli Lilly Pitches Alzheimer Drug to the FDA, Aiming to Leapfrog Biogen

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It’s an exciting if turbulent, and rather cutthroat, time in the world of Alzheimer’s drug research.

In June, the FDA greenlit Biogen’s Aduhelm — the first new Alzheimer’s drug in 18 years. And yesterday, Eli Lilly asked the agency to fast track a second: its drug donanemab. That rival hopes it will be rubber-stamped in the second half of 2022, setting the stage for what could be an Alzheimer’s drug cola war.

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Lilly is seeking the go-ahead via the controversial “accelerated approval” process, which only requires proof that it is “reasonably likely” to help. That’s the same roadmap used by Biogen to get Aduhelm to market — and resulted in some FDA employees resigning in protest. Both drugs are designed to break down amyloid, a plaque build-up in the brain believed, but not proven, to worsen Alzheimer’s. But Lilly is already planning to set itself apart:

  • It announced a head-to-head clinical trial comparing donanemab and Aduhelm to see which is better at breaking down amyloid, with results due in late 2022.
  • Unlike Biogen, Lilly is being cautious with investors warning that even if donanemab is approved next year, it doesn’t anticipate uptake until a second, long-term clinical study is released in 2023.

Backing Their Brand: Patient advocacy group the Alzheimer’s Association has cheered Aduhelm’s hasty approval despite the controversy, its $56,000-a-year price tag, and reports that government officials are looking into allegations of an “inappropriately close relationship” between Biogen and the FDA.

Watching, waiting: The Biden administration is currently considering whether Medicare will cover Aduhelm. Since many insurers take cues from the program, that decision could ultimately help both Biogen and Lilly. In the meantime, we’ll just have to wait and see if either drug really helps.

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