echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Study of Nervous System > Johnson and Johnson submitted a market application for a new adaptation of Darzalex injections to treat light-chain amyloid degeneration.

    Johnson and Johnson submitted a market application for a new adaptation of Darzalex injections to treat light-chain amyloid degeneration.

    • Last Update: 2020-09-25
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    On September 10, Janssen announced that it had submitted to the FDA an application for a license for a supplemental biologic product for Thedarzalex Faspro (daratumumab/hyaluronoidase-fihj) subsurface injection for the treatment of patients with light-chain amyloid degeneration.
    Light-chain amyloid degeneration is a rare disease that can be life-threatening, with plasma cells in the bone marrow producing abnormal light chains that form amyloid deposits that accumulate in vital organs and eventually lead to organ degradation.
    -chain amyloid degeneration affects multiple organs in the body, most severely the heart, kidneys, liver, spleen, gastrointestinal tract and nervous system.
    because clinical symptoms in patients with light-chain amyloid can simulate other diseases, clinical diagnosis is often delayed and the prognosis is poor.
    FDA has not yet approved any drugs for the treatment of light-chain amyloid degeneration.
    Although light-chain amyloid is the most common type of amyloid degeneration, it is still a rare disease, with about 30,000 to 45,000 patients in the United States and Europe and about 4,500 newly diagnosed light-chain amyloid degeneration patients in the United States each year.
    's application is based on positive data from Phase III ANDROMEDA research.
    The study included 388 newly diagnosed patients with light-chain amyloid degeneration who were given sub-corted injections of daratumumab combined boronitazome, cyclophosphamide and dexamide (D-VCd) and VCd-only.
    results showed that the overall blood remission rate of patients in the D-VCd treatment group improved significantly compared to that in the VCd group, reaching the main endpoint.
    Daratumumab is a membrane surface protein that multiple myeloma cells express highly at any stage of growth.
    the world's first listed CD38 single-resistance developed by Janssen.
    , Daratumumab binds to CD38 and inhibits tumor cell growth, leading to myeloma cell death.
    source: Medical Rubik's Cube!-- the end of the content display -- !-- determine whether the login is over.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.