Biogen gets FDA Breakthrough status for felzartamab

US biotech major Biogen (Nasdaq: BIIB) revealed that felzartamab, an investigational anti-CD38 monoclonal antibody, has received Breakthrough Therapy designation (BTD) from the US Food and Drug Administration (FDA) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients.

Biogen pointed out that the FDA grants BTD to drug candidates for serious or life-threatening conditions and that have preliminary clinical evidence demonstrating potential to provide substantial improvement over existing therapies. The designation provides additional opportunities to engage the FDA and to support the drug development program through Fast Track designation features.

Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority and its safety and effectiveness have not been established.