Biogen: a 'breakthrough' in kidney transplant rejection

(CercleFinance.com) - Biogen reports that its felzartamab has received Breakthrough Therapy Designation (BTD) from the US FDA for the treatment of late antibody-induced rejection (AMR) in kidney transplant patients.


Antibody-induced rejection is one of the main reasons for kidney transplant failure, and patients suffering from AMR currently have enormous unmet medical needs, points out Travis Murdoch, Head of HI-Bio at Biogen.

As a reminder, the BTD offers additional opportunities to engage the FDA and support the development program of drug candidates for serious diseases that have encouraging preliminary clinical evidence.

Data from the clinical development program that supported this designation were published in the New England Journal of Medicine and presented at the 61st Congress of the European Renal Association (ERA) in Stockholm, in May 2024.


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