Biogen (BIIB) and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the approval of Leqembi (lecanemab) for mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD, collectively known as early AD, in the EU.Please note that, in November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending marketing approval for Leqembi for early AD.Biogen and Eisai annou ...

Core Viewpoint - Eisai Co., Ltd. and Biogen Inc. are progressing with the regulatory review of lecanemab for early Alzheimer's disease treatment in the European Union, following a positive recommendation from the CHMP in November 2024 [1][2]. Group 1: Regulatory Update - The European Commission has requested the CHMP to review new safety information regarding lecanemab that emerged after the initial recommendation, which will be discussed in February 2025 [2]. - The safety profile of lecanemab remains consistent with approved labels, with no new safety signals identified, indicating confidence in addressing the EC's requests with existing data [3]. Group 2: Product Development and Commercialization - Eisai leads the global development and regulatory submissions for lecanemab, with both Eisai and Biogen co-commercializing the product, while Eisai retains final decision-making authority [4][10]. - Lecanemab has received approvals in multiple countries, including the U.S., Japan, and China, and is currently under review in 17 countries, including the EU [7]. Group 3: Clinical Studies - Ongoing Phase 3 clinical studies, such as AHEAD 3-45 and Tau NexGen, are exploring lecanemab's efficacy in different stages of Alzheimer's disease, supported by public-private partnerships [9].

Biogen (BIIB) 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 administrati ...

Core Insights - The FDA has approved the Supplemental Biologics License Application for LEQEMBI, allowing for once every four weeks maintenance dosing after an initial 18-month treatment phase [1][3][31] - LEQEMBI is indicated for early Alzheimer's disease, specifically for patients with mild cognitive impairment or mild dementia [7][31] - Ongoing treatment with LEQEMBI can slow disease progression and prolong therapeutic benefits, as it continuously clears toxic protofibrils and amyloid plaques [2][5][31] Group 1: Approval and Indications - LEQEMBI is approved in multiple countries including the U.S., Japan, China, and several others, with applications submitted in 17 regions [3][30] - The treatment received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in November 2024 [3][30] - The FDA has also accepted a Supplemental Biologics License for a subcutaneous autoinjector for weekly maintenance dosing, with a PDUFA action date set for August 31, 2025 [3] Group 2: Clinical Efficacy - In the Clarity AD study, LEQEMBI reduced cognitive decline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) by 27% at 18 months compared to placebo [31] - The mean change from baseline at 18 months was -0.45 on the CDR-SB scale, indicating a statistically significant benefit [31] - The treatment also showed a 37% improvement in the Activities of Daily Living Scale for Mild Cognitive Impairment compared to placebo [31] Group 3: Mechanism of Action - LEQEMBI works by continuously clearing both protofibrils and amyloid plaques, addressing the neurotoxic processes that contribute to Alzheimer's disease [2][5] - The treatment aims to maintain cognitive function and independence for patients by reducing neuronal injury [5][6] Group 4: Safety and Monitoring - The incidence of amyloid-related imaging abnormalities (ARIA) was reported at 21% for LEQEMBI, with symptomatic ARIA occurring in 3% of patients [12][13] - Monitoring guidelines recommend baseline brain MRI and periodic assessments to manage ARIA risks effectively [23] - Infusion-related reactions were observed in 26% of patients receiving LEQEMBI, with most cases occurring during the first infusion [25][27]

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's disease progression does not stop after plaque clearance; ongoing treatment with LEQEMBI can slow disease progression and prolong the benefits of therapy TOKYO and CAMBRIDGE, Mass., Jan. 26, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbache ...

Regulatory Filings and Drug Development - Biogen announced that the FDA and EMA have accepted its regulatory filings for a higher dose of Spinraza, a blockbuster spinal muscular atrophy (SMA) drug [1] - The new dosing regimen simplifies administration with two initial 50 mg doses spaced 14 days apart, followed by a 28 mg maintenance dose every four months, reducing dosing frequency compared to the current regimen [2] - The regulatory filings are supported by data from the phase II/III DEVOTE study, which showed statistically significant improvement in motor function in infants with SMA treated with a higher dose of Spinraza [3] - A higher dose regimen has the potential to slow neurodegeneration faster through greater reductions in neurofilament as early as day 64, potentially leading to meaningful clinical benefits in infants with symptomatic SMA [4] Spinraza's Market Position and Competition - Spinraza, a key revenue driver for Biogen, was developed jointly with Ionis Pharmaceuticals, with Biogen holding worldwide rights for its development, manufacturing, and commercialization [7] - Spinraza faces competition from Novartis' Zolgensma and Roche/PTC Therapeutics' Evrysdi, both approved for SMA, which has negatively impacted Spinraza's sales in the United States [7][8] - Spinraza's sales declined almost 3% year over year in 2023 and over 13% in the first nine months of 2024 due to increased competitive pressure [8] Biogen's Collaborations and Pipeline - Biogen and Ionis have a collaboration agreement for Qalsody (tofersen), which received FDA accelerated approval in April 2023 for treating adult patients with SOD1-ALS and was also approved in the EU [10] - Biogen and Ionis are collaborating to develop new therapies for neurological diseases, including BIIB094 for Parkinson's disease and BIIB080 for Alzheimer's disease, currently in early to mid-stage studies [11] Stock Performance - Biogen's shares have lost nearly 42% in the past year, compared to the industry's 12% decline [5]

Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMACAMBRIDGE, Mass., Jan. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen for spinal muscular a ...

Biogen Inc. Conference Call Summary Company Overview - **Company**: Biogen Inc. (NASDAQ:BIIB) - **Event**: J.P. Morgan 43rd Annual Healthcare Conference - **Date**: January 14, 2025 - **Participants**: - Chris Viehbacher - President and CEO of Biogen - Chris Schott - JPMorgan Key Points Industry Focus - **Alzheimer's Disease**: Biogen is focusing on addressing the significant unmet need in Alzheimer's, indicating a substantial commercial opportunity in this area [4] Product Launches - **Recent Launches**: Biogen executed four product launches in the previous year, which include: - LEQEMBI - SKYCLARYS - ZURZUVAE - QALSODY - The company is prioritizing strong execution on these launches in the near term [3] Pipeline Development - **Pipeline Confidence**: Biogen has made significant progress in its pipeline, with internal conviction and confidence noted regarding its potential [5] Long-term Strategy - **Focus Areas**: Biogen's long-term strategy includes a strong commitment to Alzheimer's treatment and further development of its pipeline [4] Additional Insights - **Market Opportunities**: The emphasis on Alzheimer's suggests that Biogen is positioning itself to capitalize on a growing market with high demand for effective treatments [4] - **Execution Strategy**: The focus on executing product launches indicates a proactive approach to market penetration and revenue generation [3]

TOKYO and CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. LEQEMBI is indicated for the ...

TOKYO and CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen")) announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Biologics License Application (BLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. LEQEMBI is indicated for the ...