Biogen announced that its investigational anti-CD38 monoclonal antibody, felzartamab, has received Breakthrough Therapy Designation (BTD) from the FDA for treating late antibody-mediated rejection (AMR) in kidney transplant patients. This FDA designation is given to therapies that show potential to significantly improve outcomes for patients facing serious or life-threatening conditions, providing expedited pathways for drug development.

The BTD was supported by clinical data published in the New England Journal of Medicine and presented at the European Renal Association Congress. Felzartamab addresses a key unmet need in managing AMR, a major cause of kidney transplant failure, and will allow Biogen to collaborate closely with the FDA to expedite its development. This milestone follows prior designations for felzartamab in other kidney-related conditions.

Biogen has completed Phase 2 studies of felzartamab in antibody-mediated rejection, primary membranous nephropathy (PMN), and IgA nephropathy (IgAN). The company plans to initiate Phase 3 trials in 2025, further advancing its efforts to tackle complex kidney diseases. This follows Biogen's acquisition of Human Immunology Biosciences in mid-2024.

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