Biogen/Eisai’s newly approved drug, Leqembi (lecanemab) gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. Leqembi is currently pending approval in the EU and Japan. If approved in these regions, its position would solidify as the top-selling drug for Alzheimer’s disease in the upcoming years. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9 billion between 2023 and 2028, according to GlobalData, a leading data and analytics company.

Leqembi is a monoclonal antibody that targets the amyloid beta A4 protein and acts by selectively binding and eliminating amyloid beta plaques thought to be clinically significant for the treatment of Alzheimer’s disease. The FDA decision on Leqembi was based on data from a Phase II clinical trial named Athena AD. The results of the trial showed that treatment led to a significant reduction in the amount of amyloid beta plaques in the brain and demonstrated a statistically significant reduction in cognitive decline in patients treated with Leqembi compared to those who received a placebo.

Kevin Marcaida, Pharma Analyst at GlobalData, comments: “The projection for Leqembi surpasses Aricept, the second-largest approved Alzheimer’s drug with forecast total sales of $762 million between 2023 and 2028, making Leqembi’s forecast sales 17x greater than those of Aricept.”

Leqembi’s largest market is expected to be the US, contributing $7.7 billion of 2023–28 forecast sales. The anticipated regulatory approvals for the drug in Europe and Japan in October 2023 are expected to further contribute to its revenue growth. Sales in these regions are projected to surge at a compound annual growth rate (CAGR) of 77% until 2028, accounting for 39% of the drug’s 2023–28 total revenue share.

Marcaida adds: “However, the US market remains crucial in driving the drug’s commercial success, with forecast sales projected to increase at a CAGR of 106% until 2028, accounting for 60% of the drug’s total revenue share.”

Leqembi faces competition from Eli Lilly’s donanemab, a similar monoclonal antibody targeting amyloid beta plaques with forecast total sales of $8.1 billion by 2028. However, in January 2023, the FDA rejected Eli Lilly’s bid for accelerated approval of donanemab, leaving Leqembi as the leading drug in this space.

Marcaida concludes: “Leqembi offers newfound hope to patients suffering from Alzheimer’s disease. The forecast total sales for the drug underscore the significant impact Leqembi is expected to have on the market. With the rejection of donanemab’s bid for accelerated approval, Leqembi is in a favorable position where it is now expected to emerge as one of the best-selling drugs for Alzheimer’s disease over the next few years.”