With an Accelerated nod for Aduhelm (aducanumab) and now full approval for Leqembi (lecanemab) in the USA, Biogen (Nasdaq: BIIB) and Eisai (TYO: 4523) have overturned decades of failure in Alzheimer’s.
But at the annual meeting of the Alzheimer’s Association (AAIC), it’s another neurology heavyweight taking center stage, as Eli Lilly (NYSE: LLY) makes clear its intention to remain a leader in the treatment of this challenging disease.
At the AAIC in Amsterdam, we’re speaking with two key figures from the development program for donanemab, a candidate which could slow cognitive decline for millions of people with early Alzheimer’s, while generating billions in annual revenues.
Lilly is presenting full results from a key Phase III trial of its antibody, which like Leqmebi, clears aberrant proteins from the brain with the goal of combatting neurodegeneration.
There are important differences between the way the two molecules work, however, and Lilly is confident its approach, which includes limited duration dosing, offers the best chance of success.
The new data, which form part of a regulatory submission for approval in the USA, seem to bear this out. As with other therapies in this class, all eyes will be on safety, and Lilly hopes that “treating to clear,” and then holding off on dosing, could help avoid side effects.
Like Eisai, Lilly is also interested in developing a subcutaneous treatment in future, with early data for another molecule, remternetug, showing strong potential in this regard.
We discuss all of this and more, in Episode 24 of The Pharma Letter Podcast.