The US Food and Drug Administration (FDA) has approved B-cell depletion agents Inebilizumab-cdon (Uplizna, amgen) for the treatment of immunoglobulin G4-related diseases (IgG4-RD).
It is the first and only treatment approved in the US for this rare autoimmune disease. An estimated 200,000 people in the US live with IGG4-RD. press release From amgen.
“Uplizna’s FDA approval marks an important turning point for physicians with IgG4-RD patients and currently having proven treatments targeting key drivers of the disease. “We are proud to be able to provide treatments that could significantly improve the care of patients with IgG4-RD, and we continue to be encouraged by the wider possibilities of Uplizna in other immune-mediated diseases, such as thalamic spectrum disorders and generalized neuromyosis.” Mystic muscles. ”
Approval of this CD19+ B cell Targeted Therapy Supported by Phase 3, randomized, double-blind trial results Reduce. In this study, patients treated with Inebilizumabukudon had an 87% reduction in risk of flare compared to the placebo group. The result was It’s published online nEW England Journal of Medicine It was presented at the Annual Meeting of the American Society of Rheumatology on November 14th.
Inebilizumab-CDON was previously approved in 2020 by the FDA for neuromysiopathic thalamohiapharynneuritis (NMOSD) in adults with anti-aquaporin-4 antibody positive. Orphan drugs By FDA for the treatment of systemic myassimus muscle.
The initial dose of the inevilizumab system is 300 mg, administered intravenously, followed by a second intravenous infusion of 300 mg two weeks later. After these two treatments, a single intravenous infusion of 300 mg is given every six months.
The most common side effects of the inebilizumab system in patients treated with IgG4-RD were urinary tract infections and lymphopenia. The most common side effects in treating NMOSD were urinary tract infections and joint pain.
This drug is contraindicated in active patients Hepatitis B Infection, active or untreated potential tuberculosisand previous life-threatening infusion reactions to ricevilizumab cDon.
“Targeting CD19+ B cells using Uplizna has proven to be a highly effective approach to addressing the pathophysiology of IgG4-RD,” said MD (MD), the lead investigator of the MITIGATE trial in an Amgen press release. He is a professor of medicine at Harvard Medical School and is the Edward A. Fox Chair of Medicine at Massachusetts General Hospital in Boston. “Currently, the clinical community is making FDA-approved therapeutic innovations to patients who can target underlying disease mechanisms and help control disease activity by reducing IgG4-RD flare,” he added.
