The FDA recently approved a new indication for an infused therapy, Uplizna (inebilizumab-cdon) from Amgen. While the therapy was originally approved in 2020, this approval elevates Uplinza in the specialty pharmacy category as it is now the first and only therapy approved for adults living with Immunoglobulin G4-related disease (IgG4-RD). IgG4-RD is a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs.
In an NIH study, the incidence of IgG4-RD was 1.39 per 100 000 in the USA in 2019. That translates into ~3500 people with an IgG4-RD diagnosis in 2025. Uplizna was granted a breakthrough drug status.
IgG4-RD can occur in multiple organs and lead to fibrosis and permanent organ damage. Patients will take two initial loading doses followed by infusions every six months, leading to an annual cost of $280,497 after the first year.
Amgen did not release any details related to distribution.
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Uplizna (Inebilizumab-Cdon) Is Now the First and Only FDA-Approved Treatment For Igg4-Related Disease
CLICK HERE to read the full press release
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