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BIIB Secures FDA Nod for Monthly Maintenance Dosing of Alzheimer's Drug
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Biogen (BIIB - Free Report) announced that the FDA has approved a monthly maintenance dosing version for its intravenously (IV) administered Alzheimer's disease (AD) drug, Leqembi.
Post the FDA approval, patients have the option to transition to a monthly maintenance dosing regimen of Leqembi after completing an 18-month course of biweekly infusions of the drug. Alternatively, patients can also opt to continue with the biweekly dosing regimen.
The new option provides relief to AD patients taking Leqembi, as IV administrations are time-consuming — nearly one hour for each infusion. The FDA’s latest approval is supported by modeling simulations of data from multiple clinical studies, which indicate that transitioning to a monthly maintenance version of the drug could sustain both clinical and biomarker benefits.
Leqembi was initially approved by the FDA in 2023 as a biweekly medication (for both initial and maintenance dosing) to treat AD patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as ‘early AD’). A regulatory filing for the drug for a similar indication is currently under review in the European Union.
Biogen has developed Leqembi in collaboration with Japan-based Eisai, with the latter leading the clinical development and regulatory submissions. Though both companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority.
BIIB’s Stock Performance
Shares of Biogen have lost nearly 41% in the past year compared with the industry’s 12% decline.
Image Source: Zacks Investment Research
Other Updates on Biogen/Eisai’s Leqembi
A regulatory filing for Leqembi is currently under the FDA’s review seeking approval for a subcutaneous (SC) maintenance dosing version of Leqembi. A final decision is expected by Aug. 31, 2025. If approved, this SC version could be used by patients at home or medical centers as the process takes less time than the IV formulation of the drug.
Though the drug’s launch was initially slow, sales started picking up in 2024. Eisai recorded nearly $67 million in global revenues from Leqembi sales in the third quarter of 2024, showing a strong improvement from $40 million in the second quarter of 2024.
Eisai and Biogen believe that Leqembi has the potential to generate blockbuster sales as there is a huge unmet medical need for AD.
Other Players in the AD Space
AD is a progressive condition caused by a neurotoxic process that persists before and after amyloid-beta (Aβ) plaque removal. Biogen/Eisai’s Leqembi is designed to address AD through dual mechanisms, continuously clearing toxic protofibrils and rapidly removing Aβ plaque. Continuous treatment is critical as protofibrils can cause ongoing neuronal damage even after plaque clearance.
The AD market is highly competitive as a few other pharma companies like Eli Lilly (LLY - Free Report) and Prothena Corporation (PRTA - Free Report) have antibody candidates targeting the indication.
Lilly received FDA approval for Kisunla in 2024, making it the second drug on the market to treat AD after Leqembi. The LLY drug is based on a similar mechanism as Leqembi, also designed to reduce the accumulation of Aβ plaque in the brain.
Prothena is evaluating multiple AD candidates in early-stage studies targeting AD indication. PRTA is evaluating AD drug PRX012, also an amyloid-targeting therapy, in an early-stage study. Prothena is also developing a dual Aβ-tau vaccine, PRX123, a potential prevention and treatment for AD.
Image: Shutterstock
BIIB Secures FDA Nod for Monthly Maintenance Dosing of Alzheimer's Drug
Biogen (BIIB - Free Report) announced that the FDA has approved a monthly maintenance dosing version for its intravenously (IV) administered Alzheimer's disease (AD) drug, Leqembi.
Post the FDA approval, patients have the option to transition to a monthly maintenance dosing regimen of Leqembi after completing an 18-month course of biweekly infusions of the drug. Alternatively, patients can also opt to continue with the biweekly dosing regimen.
The new option provides relief to AD patients taking Leqembi, as IV administrations are time-consuming — nearly one hour for each infusion. The FDA’s latest approval is supported by modeling simulations of data from multiple clinical studies, which indicate that transitioning to a monthly maintenance version of the drug could sustain both clinical and biomarker benefits.
Leqembi was initially approved by the FDA in 2023 as a biweekly medication (for both initial and maintenance dosing) to treat AD patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as ‘early AD’). A regulatory filing for the drug for a similar indication is currently under review in the European Union.
Biogen has developed Leqembi in collaboration with Japan-based Eisai, with the latter leading the clinical development and regulatory submissions. Though both companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority.
BIIB’s Stock Performance
Shares of Biogen have lost nearly 41% in the past year compared with the industry’s 12% decline.
Image Source: Zacks Investment Research
Other Updates on Biogen/Eisai’s Leqembi
A regulatory filing for Leqembi is currently under the FDA’s review seeking approval for a subcutaneous (SC) maintenance dosing version of Leqembi. A final decision is expected by Aug. 31, 2025. If approved, this SC version could be used by patients at home or medical centers as the process takes less time than the IV formulation of the drug.
Though the drug’s launch was initially slow, sales started picking up in 2024. Eisai recorded nearly $67 million in global revenues from Leqembi sales in the third quarter of 2024, showing a strong improvement from $40 million in the second quarter of 2024.
Eisai and Biogen believe that Leqembi has the potential to generate blockbuster sales as there is a huge unmet medical need for AD.
Other Players in the AD Space
AD is a progressive condition caused by a neurotoxic process that persists before and after amyloid-beta (Aβ) plaque removal. Biogen/Eisai’s Leqembi is designed to address AD through dual mechanisms, continuously clearing toxic protofibrils and rapidly removing Aβ plaque. Continuous treatment is critical as protofibrils can cause ongoing neuronal damage even after plaque clearance.
The AD market is highly competitive as a few other pharma companies like Eli Lilly (LLY - Free Report) and Prothena Corporation (PRTA - Free Report) have antibody candidates targeting the indication.
Lilly received FDA approval for Kisunla in 2024, making it the second drug on the market to treat AD after Leqembi. The LLY drug is based on a similar mechanism as Leqembi, also designed to reduce the accumulation of Aβ plaque in the brain.
Prothena is evaluating multiple AD candidates in early-stage studies targeting AD indication. PRTA is evaluating AD drug PRX012, also an amyloid-targeting therapy, in an early-stage study. Prothena is also developing a dual Aβ-tau vaccine, PRX123, a potential prevention and treatment for AD.
Biogen Inc. Price
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BIIB’s Zacks Rank
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.