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

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.
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