By Investing.com — Shares in Biogen (NASDAQ:BIIB) were trading marginally higher after the company said its investigational antibody felzartamab had received breakthrough therapy designation from US regulators as a treatment for late antibody-mediated rejection in kidney transplant patients.
In a statement on Tuesday, Massachusetts-based Biogen said the designation from the US Food and Drug Administration is given to drug candidates for serious or life-threatening conditions.
These medicine candidates have also shown preliminary evidence of providing substantial improvement over existing therapies, Biogen noted.
“Antibody-mediated rejection (AMR) is a major reason why kidney transplants fail, and currently patients suffering from AMR have tremendous unmet medical need,” said Travis Murdoch, Head of Biogen’s Human Immunology, or HI-Bio, unit.
“We are focused on tackling this important challenge, and the breakthrough therapy designation will enable us to work efficiently with the FDA to accelerate development of felzartamab in AMR.”
AMR is a disease where the immune system makes antibodies that damage transplanted organs.
Biogen said it plans to initiate late-stage trials for felzartamab across AMR and two other forms of kidney diseases in 2025. The treatment is still in an investigational phase, has not yet been approved by any regulatory authority, and its safety and effectiveness have not been established, Biogen flagged.
The announcements come after Biogen agreed to buy HI-Bio for up to $1.8 billion in May as part of a push to bolster its portfolio of rare disease medicines. The deal saw Biogen pay $1.15 billion in upfront costs and up to an additional $650 million if felzartamab hits certain development markers.
HI-Bio’s felzartamab has previously completed mid-stage studies for a type of kidney disease called primary membranous nephropathy, as well as AMR. The San Francisco-based group is also testing felzartamab in patients with IgA nephropathy, another version of chronic kidney disease.
(Reuters contributed reporting.)
