Amgen’s Uplizna Receives the US FDA’s Approval for Immunoglobulin G4-related Disease (IgG4-RD)
Shots:
- The US FDA has approved Uplizna to treat adults with IgG4-RD; regulatory filings for gMG are underway, with completion expected in H1’25
- Approval was based on P-III (MITIGATE) trial assessing Uplizna (n=68) vs PBO (n=67) in IgG4-RD adults, which incl. an optional 3yr. OLE & up to 2yrs. of safety follow-up after Uplinza discontinuation
- Trial showed 87% reduced IgG4-RD flare risk (10.3% vs 59.7% pts had a flare), lower annualized flare rates (0.10 vs 0.71), & 10x less steroid use (118 vs 1385mg), with 89.7% vs 37.3% avoiding glucocorticoids. 57.4% & 58.8% pts achieved flare-free, treatment-free & flare-free, corticosteroid-free complete remission, respectively, compared to 22.4% on PBO at 52wks.
Ref: Prnewswire | Image: Amgen
Related News:- Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
