FDA approves Johnson and Johnson Darzalex Faspro treatment for light chain starch...

The U.S. Food and Drug Administration (FDA) has approved Darzalex Faspro of Johnson and Johnson's Xi'an Jansen to treat newly diagnosed adult patients with light-chain amyloid degeneration.
notable, Darzalex Faspro is also the first and only FDA-approved treatment for people with this allergy.
this time, the FDA approved the drug in a joint use with Bortezomib, Cyclophosphamide and dexemide.
this new adaptation approval, based primarily on data from Darzalex Faspro's Phase III ANDROMEDA study.
test results showed that the patient's total blood remission rate increased by more than three times (42%) compared to the current typical treatment plan, the treatment of boronazome, cyclophosphamide, and dexamysong (VCd) alone (13%).
addition, patients with Darzalex's combined medication program also achieved higher total hematological remission rates (92% vs. 77%).
compared to the current typical VCd treatment, darzalex combined drug use also extends the progression-free survival (MOD-PFS) of patients with deterioration of vital organs and the event-free life of patients (MOD-EFS).
the study, the safety of the combined drug was consistent with that of Darzalex off-the-skin preparations or VCd solutions.
light-chain amyloid is a blood disorder associated with abnormal proteins that can lead to degeneration of vital organs, especially the heart, kidneys and liver.
the company does not recommend the drug for patients with NYHA IIB or IV heart disease or Mayo IIIB stage light-chain amyloid degeneration outside of controlled clinical trials.
, 4,500 people worldwide suffer from light-chain amyloid degeneration.
about a third of patients see an average of five or more doctors before they finally get an accurate diagnosis, while 72 percent are diagnosed more than a year after their first symptoms.
the prognosis of such patients is usually poor due to delays in diagnosis, with about 30% of patients with light-chain amyloidosis dying in the first year of diagnosis.
Darzalex Faspro was originally developed by Genmab and in May last year the drug was approved for four treatments for multiple myeloma (MM), including for newly diagnosed multiple myeloma patients, multiple myeloma patients who are not eligible for transplantation, and patients with recurring or resusable multiple myeloma.
Darzalex Faspro, which includes daratumumab and hyalurase-fihj, is a new subsurfacial injection (SC) preparation for Darzalex.
, Darzalex Faspro's application to treat the disease is also under review by EU regulators.
source: FDA Approves J.and J's Darzalex Faspro for Rare Light Chain Amyloidosis