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FDA approves Amgen's Uplizna in IgG4-related disease

Summary by Endpoints News

The FDA on Thursday approved Amgen’s rare disease drug Uplizna in an autoimmune disorder, setting the stage for the therapy to gain a foothold in the rare disease market. Uplizna is now approved to treat ...

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Inside Precision Medicine

Uplizna Becomes First Drug Approved for Rare Disease IgG4-R

The FDA has approved Amgen’s Uplizna as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD)—a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs including the pancreas, liver, and kidneys. LgG4-RD affects an estimated 20,000 people in the United States alone. Although it’s not entirely clear how Uplizna works, it targets CD19+ B cells. Uplizna was already ap…

8 hours ago

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Pharmaphorum

Uplizna is first drug FDA-cleared for rare disease IgG4-RD

Amgen has bagged a second indication for its B cell-depleting therapy Uplizna after the FDA cleared it for rare inflammatory disease IgG4-RD.

14 hours ago

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hcplive.com

FDA Approves Inebilizumab (Uplizna) as First IgG4-RD Therapy for Adults

Regulatory approval of inebilizumab for immunoglobulin G4-related disease (IgG4-RD) marks the first and only available treatment for adults.

1 day ago

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ajmc.com

Inebilizumab FDA Approved as First Treatment for IgG4-RD

Inebilizumab-cdon (Uplizna; Amgen) was approved as the first and only treatment for immunoglobulin G4–related disease (IgG4-RD), a chronic and debilitating immune-mediated inflammatory condition.

1 day ago

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