The Investor
31 Mar 2026, 14:02
Sanofi announced that the European Commission has granted conditional approval for its drug Rezurock (belumosudil) to treat chronic graft-versus-host disease (GVHD) in patients aged 12 and older.
The treatment is intended for patients with limited options after previous therapies have failed, addressing a serious and potentially life-threatening condition following stem cell transplantation.
The approval is based on clinical studies, including the ROCKstar trial, which demonstrated a strong response rate and durable benefits, with the therapy generally well tolerated.
Rezurock is already approved in multiple markets, including the U.S., UK, and Canada, and the EU authorization is conditional on further confirmatory studies, reflecting ongoing clinical evaluation.
The treatment is intended for patients with limited options after previous therapies have failed, addressing a serious and potentially life-threatening condition following stem cell transplantation.
The approval is based on clinical studies, including the ROCKstar trial, which demonstrated a strong response rate and durable benefits, with the therapy generally well tolerated.
Rezurock is already approved in multiple markets, including the U.S., UK, and Canada, and the EU authorization is conditional on further confirmatory studies, reflecting ongoing clinical evaluation.
