08:24 AM EDT, 10/09/2024 (MT Newswires) -- Biogen (BIIB) said Wednesday that its investigational drug felzartamab was granted breakthrough therapy designation by the US Food and Drug Administration to treat late antibody-mediated rejection without T-cell mediated rejection in kidney transplant patients.

The company said it plans to initiate phase 3 trials in 2025 for felzartamab in antibody-mediated rejection as well as in the treatment of IgA nephropathy and primary membranous nephropathy.

Felzartamab was earlier granted orphan drug designation for development in the treatment of antibody-mediated rejection as well as breakthrough therapy designation and orphan drug designation to treat primary membranous nephropathy in kidney transplant recipients, Biogen said.

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