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Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in Europe
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Biogen Inc.’s (BIIB - Free Report) Japan-based partner, Eisai announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending marketing approval for Leqembi (lecanemab) for early Alzheimer’s disease.
The CHMP recommended marketing approval for Leqembi as a treatment of adult patients with early Alzheimer’s disease who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology in Europe.
A final decision from the European Commission is expected within 67 days of receipt of the CHMP opinion.
Shares of Biogen have plunged 36.3% year to date compared with the industry’s decline of 4.5%.
Image Source: Zacks Investment Research
The CHMP had earlier given a negative opinion regarding marketing approval for Leqembi for early Alzheimer's disease in July 2024.
The negative opinion was reportedly due to a brain swelling side effect called amyloid-related imaging abnormalities associated with the use of anti-amyloid therapies like Leqembi. Eisai requested the CHMP to re-examine its opinion.
BIIB, Eisai's Leqembi Approved in Other Countries
Leqembi gained full approval from the FDA for early Alzheimer's disease in the United States and broad reimbursement from the Centers for Medicare & Medicaid Services in July 2023. This is also approved in China and Japan.
Leqembi was recently approved in some other countries like Israel, Hong Kong, South Korea, the UAE and Great Britain.
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.
Other Updates on BIIB & Eisai's Leqembi
Last month, Eisai completed the rolling submission of a biologics license application (“BLA”) to the FDA seeking approval for Leqembi subcutaneous (SC) autoinjector as a weekly maintenance dosing for the treatment of early Alzheimer's disease. The company completed the rolling submission of the BLA after the FDA granted it Fast Track designation.
The Prescription Drug User Fee Act (PDUFA) action date will be set, once the regulatory body in the United States accepts the above BLA.
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.
Meanwhile, the FDA 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 in June.
A decision from the regulatory body for the maintenance IV dosing version of Leqembi is expected on Jan. 25, 2025.
Though the Leqembi launch was slow, sales have picked up in 2024 so far. 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 Alzheimer's disease.
Other Players in the Alzheimer's Disease Market
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 July, Lilly received FDA approval for Kisunla (donanemab) for treating early symptomatic Alzheimer's disease. Kisunla was also approved in Japan and Great Britain this year.
Lilly believes Kisunla can generate blockbuster sales.
LLY’s Kisunla is only the second drug on the market to treat Alzheimer's disease after Leqembi.
Besides, 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.
PRTA expects to report multiple clinical data readouts starting in mid-2025.
Prothena is also developing a dual Aβ-Tau vaccine, PRX123, a potential prevention and treatment for AD.
Image: Shutterstock
Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in Europe
Biogen Inc.’s (BIIB - Free Report) Japan-based partner, Eisai announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending marketing approval for Leqembi (lecanemab) for early Alzheimer’s disease.
The CHMP recommended marketing approval for Leqembi as a treatment of adult patients with early Alzheimer’s disease who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology in Europe.
A final decision from the European Commission is expected within 67 days of receipt of the CHMP opinion.
Shares of Biogen have plunged 36.3% year to date compared with the industry’s decline of 4.5%.
Image Source: Zacks Investment Research
The CHMP had earlier given a negative opinion regarding marketing approval for Leqembi for early Alzheimer's disease in July 2024.
The negative opinion was reportedly due to a brain swelling side effect called amyloid-related imaging abnormalities associated with the use of anti-amyloid therapies like Leqembi. Eisai requested the CHMP to re-examine its opinion.
BIIB, Eisai's Leqembi Approved in Other Countries
Leqembi gained full approval from the FDA for early Alzheimer's disease in the United States and broad reimbursement from the Centers for Medicare & Medicaid Services in July 2023. This is also approved in China and Japan.
Leqembi was recently approved in some other countries like Israel, Hong Kong, South Korea, the UAE and Great Britain.
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.
Other Updates on BIIB & Eisai's Leqembi
Last month, Eisai completed the rolling submission of a biologics license application (“BLA”) to the FDA seeking approval for Leqembi subcutaneous (SC) autoinjector as a weekly maintenance dosing for the treatment of early Alzheimer's disease. The company completed the rolling submission of the BLA after the FDA granted it Fast Track designation.
The Prescription Drug User Fee Act (PDUFA) action date will be set, once the regulatory body in the United States accepts the above BLA.
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.
Meanwhile, the FDA 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 in June.
A decision from the regulatory body for the maintenance IV dosing version of Leqembi is expected on Jan. 25, 2025.
Though the Leqembi launch was slow, sales have picked up in 2024 so far. 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 Alzheimer's disease.
Other Players in the Alzheimer's Disease Market
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 July, Lilly received FDA approval for Kisunla (donanemab) for treating early symptomatic Alzheimer's disease. Kisunla was also approved in Japan and Great Britain this year.
Lilly believes Kisunla can generate blockbuster sales.
LLY’s Kisunla is only the second drug on the market to treat Alzheimer's disease after Leqembi.
Besides, 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.
PRTA expects to report multiple clinical data readouts starting in mid-2025.
Prothena is also developing a dual Aβ-Tau vaccine, PRX123, a potential prevention and treatment for AD.
Zacks Rank of BIIB
Biogen currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here