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LEQEMBI(R) Pen (subcutaneous formulation of LEQEMBI(R) approved in Japan for the treatment of early Alzheimer's Disease. The first and only anti-amyloid treatment in Japan that enable at-home administration for Alzheimer's Disease, a progressive disease. TOKYO and CAMBRIDGE, Mass., Sept. 16, 2026 (GLOBE NEWSWIRE) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced today that "LEQEMBI(R) Pen", the subcutaneous (SC) formulation of the anti-amyloid beta (Aβ) protofibril antibody "LEQEMBI(R)" (brand name, generic name: lecanemab) has been approved in Japan as a new route of administration. LEQEMBI Pen is an autoinjector formulation that enables administration by a care partner or patient self-administration, with two pens (totaling 500 mg) administered once weekly. With this approval, LEQEMBI treatment now offers a new option of once-weekly SC administration at home*, in addition to intravenous (IV) administration every two weeks in a hospital setting. LEQEMBI Pen may reduce the time required for anti-amyloid therapy administration compared with IV infusions (approximate injection time of 15 seconds per injection). In addition, at-home administration may reduce the burden of clinic visits for patients and their care partners and provide greater flexibility in treatment, allowing patients to make treatment choices that better fit their lifestyles, including fewer constraints on going out and traveling. The improved convenience and flexibility of treatment with LEQEMBI is expected to lower barriers to initiating and continuing treatment with LEQEMBI. Furthermore, LEQEMBI Pen also has the potential to reduce healthcare resources associated with IV dosing, such as nurse monitoring, as well as maintaining infusion capacity. These features are expected to contribute to further streamlining the overall Alzheimer's disease (AD) treatment pathway. For amyloid-related imaging abnormalities (ARIA) monitoring, as with IV administration, brain magnetic resonance imaging (MRI) is performed prior to initiating treatment and at specified time points after treatment initiation. AD is a progressive, relentless disease with Aβ and tau as hallmarks that is caused by a continuous underlying neurotoxic process driven by protofibrils that begins before amyloid plaque accumulation and continues after plaque removal.[1,2,] [3] Only LEQEMBI fights AD in two ways - targeting both protofibrils and amyloid plaque. This marks the third country globally to approve LEQEMBI SC formulation. This approval is based on the integrated results of data and associated modeling and simulation from the 18-month core study of the Phase 3 Clarity AD study of LEQEMBI in patients with mild cognitive impairment (MCI) due to AD or mild AD dementia (collectively referred to as early AD), as well as multiple SC administration sub-studies in its subsequent long-term extension study (LTE). Once-weekly administration of SC formulation 500 mg demonstrated similar exposure to IV administration once every two weeks and supported the expectation that the SC formulation provides efficacy comparable to that of the IV formulation. The overall safety profile of SC administration was generally similar to that of IV administration, while systemic injection/infusion-related reactions were observed less frequently with SC administration (1.4%)** than with IV administration. Eisai serves as the lead for lecanemab's development and regulatory submissions globally, with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. * At-home, self-administration using LEQEMBI Pen will be possible after it is listed in the injectable drug list designated by the Minister of Health, Labour and Welfare that health insurance doctor can administer (or prescribe), following deliberation and approval by the Central Social Insurance Medical Council, in principle within 60 days after approval. In addition, the following points are stipulated to be observed when self-administering. * When initiating administration, treatment must be administered by a physician or under the direct supervision of a physician at a medical facility. * With regard to the applicability of self-administration, the appropriateness thereof shall be carefully considered, and only after providing thorough education and training, and confirming that the patient or family member/caregiver understands the risks associated with administration of this drug and how to respond to them, and that the patient or family member/caregiver is able to reliably administer it themselves, shall self-administration be implemented under the management and guidance of a physician. ** Incidence in participants newly initiated on lecanemab treatment via SC administration, based on clinical data obtained from once-weekly subcutaneous administration of lecanemab 720 mg using vial formulations. | Eisai Co., Ltd. Public Relations Department TEL: +81 (0)3-3817-5120 Eisai Europe, Ltd. EMEA Communications Department +44 (0) 7760 619251 [email protected] Eisai Inc. (U.S.) Libby Holman +1-201-753-1945 [email protected] | Biogen Inc. Madeleine Shin +1-781-464-3260 [email protected] | | INVESTOR CONTACTS | / | | Eisai Co., Ltd. Investor Relations Department TEL: +81 (0) 3-3817-5122 | Biogen Inc. Tim Power + 1-781-464-2442 [email protected] | | / | / | Notes to Editors References * Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z * Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706. * Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503. 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Biogen MS drug monopoly suit survives as judge rejects dismissal bid. 0 Comments An Illinois federal judge on Tuesday kept alive a high-stakes antitrust battle, refusing to dismiss Walgreens and Kroger's lawsuit that accuses Biogen Inc. of illegally throttling competition for its multiple sclerosis drug Tecfidera. U.S. District Judge April Perry ruled from the bench in Chicago that the pharmacy giants have now alleged enough to show they "suffered a concrete injury as a result of Biogen's conduct." Perry had earlier granted Biogen's dismissal motion in February, finding Walgreen Co. and The Kroger Co. failed to demonstrate how the drugmaker's alleged formulary manipulation scheme produced a viable antitrust injury. This time the retailers cleared the bar. Allegations of market manipulation. Walgreens and Kroger contend the purported scheme forced them and their wholesalers to purchase and dispense far more of Biogen's costly brand-name Tecfidera than cheaper generic rivals. Their amended complaint states they run pharmacies in most states that either mandate or permit automatic substitution of a brand drug with a generic when the switch lowers patient costs. Biogen's alleged tactics, they claim, locked them into stocking and handing out the pricier branded version instead. Judge Perry acknowledged Tuesday that she, like Biogen, would have "preferred and expected to see" sharper, more explicit allegations. Yet "neither of us have the job of authoring the complaint." The revisions, she said, now allow a plausible injury to be reasonably inferred from the claim that the chains had to buy more of the higher-priced branded drugs. She ordered Biogen to respond to the complaint by Oct. 8. Coupons, formularies and a next-generation push. The pharmacy operators allege Biogen paid pharmacy benefit managers to rewrite certain health-plan formularies so that MS patients faced essentially identical out-of-pocket costs for branded Tecfidera or a competing generic. Biogen also handed insured patients coupons that made the brand appear cheaper than generics and scrambled to shift the market toward its "next-generation" drug Vumerity before generic Tecfidera could reach shelves, according to the suit. The prior complaint was tossed partly because neither plaintiff claimed it sold to any patients touched by the contested formularies or operated in states enforcing the substitution laws. While the alleged manipulation reached them by ripple effect, the judge had ruled they needed tighter facts to establish antitrust standing. Walgreens and Kroger are represented by Scott E. Perwin, Lauren C. Ravkind, Anna T. Neill and Trevor Scheetz of Sperling Kenny Nachwalter LLC. Biogen is represented by Lin W. Kahn, William D. Coglianese, Daniel Johnson, Eddie Hasdoo and Julie E. McEvoy of Jones Day.

Eisai and Biogen announced that China's National Medical Products Administration approved the subcutaneous formulation of LEQEMBI (lecanemab) for early Alzheimer's disease. This marks the first anti-amyloid therapy in China enabling at-home administration. The approved regimen involves 500mg given once weekly as two consecutive 250mg injections using an autoinjector. The application received priority review designation after submission in January 2026. Launch is planned during Eisai's fiscal year ending March 31, 2027. The subcutaneous formulation takes approximately 15 seconds per injection, significantly reducing time compared with intravenous infusions. Patients can administer treatment at home weekly, or alternatively receive intravenous administration every two weeks in hospital settings. Switching between administration methods is permitted during treatment. The approval aims to reduce clinic visit burden for patients and caregivers whilst potentially decreasing healthcare resources associated with intravenous dosing.