Chronic Graft - Versus - Host Disease (GVHD) treatment
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Sanofi Gets EU Nod for Rezurock in Chronic Graft-Vs-Host Disease
ZACKS· 2026-03-31 17:16
Core Insights - Sanofi has received conditional marketing authorization from the European Commission for Rezurock (belumosudil) to treat chronic graft-versus-host disease (GVHD) in adults and children aged 12 years and above weighing at least 40 kg, pending the completion of a confirmatory study [1][2][4] Group 1: Approval Details - The approval in the EU was anticipated following a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in January 2026 [2] - Rezurock's approval is based on safety and efficacy data from various clinical studies, including the phase II ROCKstar study, which demonstrated clinically meaningful and durable responses in patients with chronic GVHD after stem cell transplant [4][6] Group 2: Sales Performance - Rezurock sales increased by 8.7% year-over-year in 2025, amounting to €490 million, with expectations for further growth following the EU approval [6][7] - The approval is expected to drive additional sales growth in 2026 as Sanofi continues to evaluate Rezurock's safety and efficacy in other age groups and indications [8] Group 3: Market Context - Year to date, Sanofi's shares have declined by 3.8%, which is a smaller decrease compared to the industry's decline of 4.7% [3]