Takeda’s New Devices for Hyqvia Infusion Can Reduce Preparation Steps By Up to One-Half
The U.S. Food and Drug Administration has granted 510(k) clearance to Takeda’s HyHub and HyHub Duo for patients 17 years of age and older that allow HYQVIA [immune globulin infusion (human), 10% with recombinant human hyaluronidase] to be transferred from vials without using a needle in a home environment or clinical setting.
FDA Approves Gammagard Liquid ERC to Treat PI, Plans to Discontinue Gammagard SD in December 2027
The U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for individuals 2 years of age and older with primary immunodeficiency (PI).
Flebogamma (IVIG) Effective in Treating Post-Polio Syndrome
Grifols announced positive results from its Phase II/III clinical trial evaluating the efficacy and safety of Flebogamma 5% DIF (intravenous immune globulin [IVIG]) to treat patients with post-polio syndrome, which demonstrated a significant improvement in distance walked compared to placebo.
IVIG Effectively Increased Platelet Counts in Maternal Thrombocytopenia
A recent study that sought to evaluate the efficacy of intravenous immune globulin (IVIG) and identify predictors of platelet response in pregnant persons with moderate-to-severe thrombocytopenia, as well as to optimize clinical decisions and resource use, has found that IVIG effectively increases platelet counts.
Uplizna Approved to Treat IgG4-Related Disease
Amgen’s UPLIZNA has been approved by the U.S. Food and Drug Administration as the first and only treatment for adults living with Immunoglobulin G4-related disease.
Diagnosing and Treating Infant Botulism
Since the approval of BabyBIG, the only treatment for this rare but life-threatening disease affecting infants mostly under 6 months, the mortality rate is now less than 15 percent.
Update on Rabies
Though mostly eradicated in the U.S., treatment for rabies must begin immediately with hyperimmune globulin and vaccines.
Multiple Myeloma Patients Treated with Teclistamab May Benefit from IVIG Supplementation
Results of a recent study show patients with multiple myeloma undergoing teclistamab therapy may benefit from primary intravenous immune globulin supplementation, which appears to reduce the risk of high-grade infection.
Bivigam, Gamunex-C and Panzyga Lots Withdrawn
Specific lots of intravenous immune globulin (IVIG) and subcutaneous IG (SCIG) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.
Study Shows IVIG Is Associated with Sepsis Mortality
A study published in Frontiers in Immunology has found the administration of intravenous immune globulin (IVIG) is associated with a reduction in sepsis mortality and favorable outcomes in laboratory parameters and the functional status, contributing to the ongoing debate on the efficacy of IVIG for sepsis.