Biogen relying on success of Leqembi following discontinuation of Aduhelm

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Biogen’s stance at the upcoming AD/PD 2024 International Conference on Alzheimer’s disease and Parkinson’s disease will demonstrate its future plans for treating Alzheimer’s, following the discontinuation of Aduhelm (aducanumab), its anti-amyloid beta (Aβ) monoclonal antibody (mAb).

Against this backdrop, the success of Leqembi (lecanemab) remains important for Biogen amid the growing competition in the Alzheimer’s market, according to data and analytics firm GlobalData. 

Pippa Salter, senior neurology analyst at GlobalData, said: “By discontinuing Aduhelm, which has failed to have a significant impact in the market with sales revenue falling flat, Biogen can now fully focus on the continued commercialization of Eisai-partnered Leqembi (lecanemab), an anti- Aβ mAb that received full FDA approval for the treatment of mild AD and mild cognitive impairment (MCI) in July 2023.

“The success of Leqembi will be crucial for Biogen moving forward, particularly after the lack of return from the significant investment the company put into Aduhelm. Aduhelm-specific sales were excluded from the company earnings being reported by Biogen in 2023, rather the drug was included in ‘Other products’ revenue.”

Leqembi has already overcome many of the hurdles that Aduhelm faced leading to its failure, including receiving full approval from the FDA, resulting in broader coverage from the US Centers for Medicare and Medicaid Services, allowing for greater access compared with Aduhelm.

According to GlobalData's forecasts, Leqembi has the potential to generate global sales in the eight key global markets of approximately $3.5 billion in 2030.

Salter continues: “Uptake of Leqembi has been slower than expected given its status as a disease-modifying therapy for a disease with extremely limited treatment options. As the anti- Aβ mAbs are a new and very different class of drug for treating AD, a new treatment pathway is needed to aid access to the drug, and scheduling MRI and PET scans have been key limiting factors in the uptake of Leqembi.”

The success of Leqembi will likely be influenced by the progress of its closest competitor, Eli Lilly’s anti- Aβ mAb donanemab, which is expected to gain approval from the FDA by the end of Q1 2024.

Salter concludes: “While Leqembi does have the advantage of reaching the market before donanemab, there may be an advantage for donanemab in entering the market once a diagnosis and treatment pathway for anti- Aβ mAbs has become more established and streamlined. Further, while donanemab has an advantage in dosing schedule, Leqembi has a more advantageous safety profile. GlobalData forecasts that donanemab could generate global sales of approximately $2.0 billion in 2030.”