Biogen Receives FDA Breakthrough Therapy Designation for Felzartamab for Treatment of AMR

On 9 October 2024, Biogen announced that its felzartamab received FDA Breakthrough Therapy Designation (BTD) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients.  Felzartamab is an investigational anti-CD38 monoclonal antibody and is said to be a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications.