FDA Grants Orphan Drug Status to HI-Bio’s Felzartamab for Antibody-Mediated Rejection (AMR)

Significance of FDA Orphan Drug Designation for Felzartamab

The US Food and Drug Administration (FDA) has recently bestowed orphan drug designation (ODD) upon Human Immunology Biosciences’ (HI-Bio) groundbreaking therapeutic, felzartamab. This recognition is specifically for combating antibody-mediated rejection (AMR) in individuals who have undergone kidney transplants.

Felzartamab: A Promising Solution

Felzartamab, a monoclonal antibody meticulously crafted to target cluster of differentiation 38 (CD38), has demonstrated immense potential in clinical trials. This potential lies in its ability to ameliorate outcomes in diseases triggered by pathogenic antibodies.

In-Depth Look at Felzartamab’s Mechanism

The mechanism of felzartamab revolves around its targeted action on CD38, a crucial player in the generation of pathogenic antibodies. By selectively depleting CD38+ plasma cells, felzartamab effectively curtails the production of harmful antibodies, thus paving the way for improved patient outcomes.

Expanding Therapeutic Horizons

HI-Bio’s vision extends beyond just combating AMR. Felzartamab is being developed to tackle a spectrum of immune-mediated diseases, including but not limited to IgA nephropathy, lupus nephritis, and primary membranous nephropathy (PMN). This underscores the versatility and potential of this innovative therapeutic agent.

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FDA’s Recognition of Felzartamab’s Merits

It’s noteworthy that this isn’t the first time felzartamab has caught the FDA’s attention. Previously, the FDA has bestowed both breakthrough therapy and orphan drug statuses upon felzartamab, particularly for its efficacy in treating primary membranous nephropathy (PMN).


The FDA’s recent grant of orphan drug designation to felzartamab marks a significant milestone in the journey towards combating antibody-mediated rejection and other immune-mediated diseases. With promising results from clinical trials and ongoing research, felzartamab emerges as a beacon of hope for patients grappling with these challenging conditions. HI-Bio’s relentless pursuit of innovation continues to pave the way for groundbreaking advancements in the field of immunotherapy.


Allen holds a Master's degree in English Literature and boasts seven years of experience as a content writer. Specializing in Entertainment, Sports, and the latest news, he excels in crafting compelling narratives that captivate audiences. Allen's expertise in language and storytelling ensures that his content is both informative and engaging.

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