ESAIY News & Events

Eisai (ESAIY) and Biogen (BIIB) announced that Eisai has filed a new drug application for Leqembi seeking approval for a subcutaneous formulation as a new route of administration to Japan's Pharmaceuticals and Medical Devices Agency. "If approved, lecanemab would be the first and only anti-amyloid treatment in Japan to offer an at-home injection from the initiation of treatment for this progressive, relentless disease," the companies stated. 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.

Eisai Co. (ESAIY) and Biogen (BIIB) announced that Eisai has completed the rolling submission of the Supplemental Biologics License Application to the U.S. FDA for Leqembi Iqlik as a weekly starting dose after the FDA granted Fast Track Status. Leqembi is indicated for the treatment of Alzheimer's disease in patients with Mild Cognitive Impairment or mild dementia stage of disease. Upon acceptance of the sBLA, the FDA will set a Prescription Drug User Fee Act action date.

Eisai (ESAIY) and Biogen (BIIB) announced that humanized anti- soluble aggregated amyloid-beta monoclonal antibody "LEQEMBI" has been approved for once every four weeks intravenous maintenance dosing by the Medicines and Healthcare products Regulatory Agency in the United Kingdom.

Merck (MRK) and Eisai (ESAIY) announced results from the Phase 3 LEAP-012 trial evaluating Keytruda, Merck's anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with transarterial chemoembolization for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma. At a pre-specified interim analysis, Keytruda plus Lenvima in combination with TACE did not achieve statistical significance for overall survival, one of the study's primary endpoints, compared to TACE alone. The likelihood of reaching the protocol-specified threshold for statistical significance for OS at a future analysis was evaluated by Merck and Eisai and considered to be low. On this basis, the study will be closed, and the companies are informing investigators of this decision. The safety profile of the Keytruda plus Lenvima-based regimen was consistent with that observed in previously reported studies evaluating the combination and in earlier analyses of LEAP-012. Further analysis of the data is ongoing; Merck and Eisai will work with investigators to share the results with the scientific community. As reported previously, Keytruda plus Lenvima in combination with TACE met the study's other primary endpoint of progression-free survival and demonstrated a statistically significant and clinically meaningful improvement compared to TACE alone. Data from this first interim analysis, which served as the final analysis for the endpoint of PFS, were presented at the European Society for Medical Oncology Congress 2024 and published in The Lancet. With additional follow-up at subsequent analyses, PFS remained consistent.