Amyloid is a substance that forms when proteins misfold and clump together. More than 50 conditions are linked to the accumulation of amyloid, including Alzheimer’s and Parkinson’s diseases.

Three Alzheimer’s disease drugs that target amyloid have been authorized by the US Food and Drug Administration in recent years.

Biogen’s Aduhelm (aducanumab-avwa) was the first of its kind to be approved, but it failed to secure regulatory approval in other markets, including the EU, and was discontinued by the company in January.(Also see "Biogen Closes The Book On The Aduhelm Saga" - Pink Sheet, 31 January, 2024.).

The two other anti-amyloid drugs are Eli Lilly’s Kisunla (donanemab-azbt) and Biogen/Eisai’s Leqembi (lecanemab-irmb).

Kisunla was authorized in the US on 2 July, while Leqembi received an accelerated approval in January 2023, which was converted to regular approval six months later. (Also see "Lilly’s Kisunla: Labeling Allows For Stopping Treatment Based On Amyloid Plaque Reduction" - Pink Sheet, 2 July, 2024.).

Neither drug has been authorized in the EU yet, but the EMA's advisory committee is expected to issue an opinion on whether lecanemab should be approved this week.

There has been much controversy in the scientific community around the role of amyloid in Alzheimer’s disease, and the exact mechanism by which it contributes to cognitive decline has yet to be established.(Also see "Why Protein Misfolding Diseases Have Been Pharma’s Achilles Heel" - In Vivo, 20 March, 2024.).

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