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Biogen (BIIB) & Eisai's Leqembi sBLA Gets FDA Acceptance
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Biogen (BIIB - Free Report) and Japanese partner Eisai announced that the FDA has accepted Eisai’s supplemental biologics license application (sBLA) seeking approval for a maintenance intravenous (“IV”) dosing version of Leqembi for the treatment of early Alzheimer’s disease. The FDA is expected to give its decision on the sBLA on Jan 25, 2025.
Leqembi was approved as an injection for intravenous use by the FDA for early Alzheimer’s disease in the United States in July 2023. Leqembi is also approved in China and Japan. Regulatory applications seeking approval of Leqembi are under review in Europe.
Eisai completed the submission of a rolling BLA to the FDA for the maintenance intravenous dosing version of Leqembi in March this year. The patients who have completed the biweekly IV initiation phase would receive a monthly IV dose as part of the proposed monthly IV maintenance regimen to maximize patient outcomes. Biogen believes the IV dose will maintain effective drug concentration to allow sustainable removal of highly toxic protofibrils. Protofibrils are the most toxic form of amyloid beta (Aβ) plaques, which are believed to contribute to the brain injury that leads to cognitive decline associated with Alzheimer’s disease.
Biogen’s stock has declined 12.9% so far this year compared with a decrease of 5.9% for the industry.
Image Source: Zacks Investment Research
Biogen and Eisai have also developed a weekly maintenance therapy using a subcutaneous (SC) administration. Eisai initiated a rolling BLA submission of the subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA in May 2024. If approved, the autoinjector SC version of Leqembi could be used by patients at home or at medical centers as the process takes less time than the IV formulation of the drug.
Though the Leqembi launch is progressing slowly, Biogen believes it has the potential to generate blockbuster sales as there remains a massive unmet need for Alzheimer's disease. Biogen expects sales of Leqembi to start growing from 2024 with signs of acceleration seen in the first quarter.
Biogen has developed Leqembi in collaboration with Eisai, with the latter leading the clinical development and regulatory submissions. Though the companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority.
Alzheimer's disease is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and Aβplaques in the brain. The Alzheimer's disease 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 Alzheimer’s disease indication in their pipeline.
Eli Lilly developed donanemab, its antibody therapy for Alzheimer's disease, which is currently under review with the FDA. In March 2024, the FDA delayed its decision on the donanemab filing, which was initially expected before the end of the first quarter of 2024.
An in-person meeting of the Peripheral and Central Nervous System Drugs Advisory Committee is scheduled today to discuss the safety and efficacy profile of donanemab based on data from the phase III TRAILBLAZER-ALZ 2 study, which supported Lilly’s BLA for donanemab.
Prothena’s Alzheimer’s candidate is PRX012, a next-generation subcutaneous antibody targeting a key epitope at the N-terminus of Aβ. PRX012 is in early-stage development. The FDA has granted Fast Track Designation to PRX012 for the treatment of Alzheimer's disease. Prothena is also developing a dual Aβ-tau vaccine, PRX123, a potential prevention and treatment for Alzheimer's disease.
Image: Bigstock
Biogen (BIIB) & Eisai's Leqembi sBLA Gets FDA Acceptance
Biogen (BIIB - Free Report) and Japanese partner Eisai announced that the FDA has accepted Eisai’s supplemental biologics license application (sBLA) seeking approval for a maintenance intravenous (“IV”) dosing version of Leqembi for the treatment of early Alzheimer’s disease. The FDA is expected to give its decision on the sBLA on Jan 25, 2025.
Leqembi was approved as an injection for intravenous use by the FDA for early Alzheimer’s disease in the United States in July 2023. Leqembi is also approved in China and Japan. Regulatory applications seeking approval of Leqembi are under review in Europe.
Eisai completed the submission of a rolling BLA to the FDA for the maintenance intravenous dosing version of Leqembi in March this year. The patients who have completed the biweekly IV initiation phase would receive a monthly IV dose as part of the proposed monthly IV maintenance regimen to maximize patient outcomes. Biogen believes the IV dose will maintain effective drug concentration to allow sustainable removal of highly toxic protofibrils. Protofibrils are the most toxic form of amyloid beta (Aβ) plaques, which are believed to contribute to the brain injury that leads to cognitive decline associated with Alzheimer’s disease.
Biogen’s stock has declined 12.9% so far this year compared with a decrease of 5.9% for the industry.
Image Source: Zacks Investment Research
Biogen and Eisai have also developed a weekly maintenance therapy using a subcutaneous (SC) administration. Eisai initiated a rolling BLA submission of the subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA in May 2024. If approved, the autoinjector SC version of Leqembi could be used by patients at home or at medical centers as the process takes less time than the IV formulation of the drug.
Though the Leqembi launch is progressing slowly, Biogen believes it has the potential to generate blockbuster sales as there remains a massive unmet need for Alzheimer's disease. Biogen expects sales of Leqembi to start growing from 2024 with signs of acceleration seen in the first quarter.
Biogen has developed Leqembi in collaboration with Eisai, with the latter leading the clinical development and regulatory submissions. Though the companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority.
Alzheimer's disease is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and Aβplaques in the brain. The Alzheimer's disease 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 Alzheimer’s disease indication in their pipeline.
Eli Lilly developed donanemab, its antibody therapy for Alzheimer's disease, which is currently under review with the FDA. In March 2024, the FDA delayed its decision on the donanemab filing, which was initially expected before the end of the first quarter of 2024.
An in-person meeting of the Peripheral and Central Nervous System Drugs Advisory Committee is scheduled today to discuss the safety and efficacy profile of donanemab based on data from the phase III TRAILBLAZER-ALZ 2 study, which supported Lilly’s BLA for donanemab.
Prothena’s Alzheimer’s candidate is PRX012, a next-generation subcutaneous antibody targeting a key epitope at the N-terminus of Aβ. PRX012 is in early-stage development. The FDA has granted Fast Track Designation to PRX012 for the treatment of Alzheimer's disease. Prothena is also developing a dual Aβ-tau vaccine, PRX123, a potential prevention and treatment for Alzheimer's disease.
Biogen currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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