Tag: Submits
Japan – Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Europe
Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) to the European Medicines Agency (EMA). This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD, and is subject to a ... Read more
Japan – Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
Eisai Co., Ltd. and Biogen Inc. announced Eisai has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) supporting the conversion of the Accelerated Approval of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use to a traditional approval. This sBLA is subject to validation of whether the FDA accepts the application for review. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (“protofibrils”)* and insoluble forms of amyloid beta (Abeta), approved under Accelerated Approval Pathway by the FDA on January 6, 2023, for the treatment of Alzheimer’s Disease (AD). ... Read more
Janssen Submits Biologics License Application to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
, including in the sections captioned Cautionary Note Regarding Forward-Looking Statements and Item 1A. Risk Factors, and in the companys most recently filed Quarterly Report on Form 10-Q, and the companys subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
[1] Moreau P et al. Updated Results From MajesTEC-1: Phase 1/2 Study of Teclistamab, a B-Cell Maturation Antigen x ... Read more