Sanofi’s Rezurock Receives Positive CHMP Recommendation, Advancing New Treatment Option for Chronic GVHD in Europe

Sanofi’s Rezurock Receives Positive CHMP Recommendation, Advancing New Treatment Option for Chronic GVHD in Europe

(IN BRIEF) Sanofi has received a positive recommendation from the European Medicines Agency’s CHMP for the conditional approval of Rezurock to treat late-line chronic graft-versus-host disease in adults and adolescents aged 12 and older. The opinion, based on clinical trial results and real-world evidence, follows a re-examination of a prior negative decision and reflects the urgent need for new treatment options for patients with limited therapeutic alternatives. Supported by data from the ROCKstar phase 2 study and accompanied by a commitment to further confirmatory research, the recommendation brings Rezurock closer to becoming an approved option in the EU, expanding access to a therapy already used by more than 17,000 patients globally.

(PRESS RELEASE) PARIS, 30-Jan-2026 — /EuropaWire/ — Sanofi has taken a significant step toward expanding treatment options for patients with chronic graft-versus-host disease (GVHD) in Europe after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending conditional marketing authorisation for Rezurock (belumosudil). The recommendation applies to adult patients and to adolescents aged 12 years and older weighing at least 40 kg whose disease has shown limited response to, is unsuitable for, or has exhausted other available therapies. A final decision from the European Commission is expected in the coming weeks.

The positive opinion follows a re-examination requested by Sanofi after an earlier negative CHMP opinion issued in October 2025. The committee’s revised position reflects a comprehensive review of safety and efficacy data drawn from multiple clinical studies and real-world evidence, highlighting the potential of Rezurock to address a major unmet medical need in late-line chronic GVHD.

Chronic GVHD is a complex, multi-organ condition that can develop after allogeneic stem cell transplantation and often has a profound impact on patients’ physical health, daily functioning, and emotional wellbeing. For individuals who have exhausted standard treatment options, therapeutic alternatives remain limited, particularly in Europe. The CHMP’s recommendation is therefore viewed as a meaningful development for patients and clinicians managing this challenging disease.

The recommendation is supported by data from the pivotal ROCKstar phase 2 study, a randomised, multicentre clinical trial that demonstrated clinically meaningful and durable responses in patients with chronic GVHD who had previously received at least two lines of systemic therapy. Treatment with Rezurock was generally well tolerated, and under the terms of the conditional approval, Sanofi has committed to conducting an additional confirmatory randomised controlled study to further substantiate long-term benefit.

Rezurock is already approved in 20 countries, including the United States, the United Kingdom, and Canada, for patients aged 12 years and older with chronic GVHD following failure of at least two prior systemic therapies, and in China after failure of one prior line of therapy. Since its first approval in the US in July 2021, more than 17,000 patients worldwide have been treated with Rezurock.

Rezurock is a first-in-class selective ROCK2 inhibitor and represents Sanofi’s ongoing commitment to advancing therapies for rare and complex immune-mediated conditions. In parallel with the EU review, the company continues to investigate the medicine’s potential in additional age groups and indications, including paediatric chronic GVHD from one year of age and chronic lung allograft dysfunction, as part of its broader research programme.

About chronic graft-versus-host disease
GVHD is a life-threatening complication that can occur following stem cell transplant (or allogeneic hematopoietic stem cell transplant) where the donor’s (graft) cells attack the host’s cells, leading to inflammation and fibrosis (scarring or thickening) that can damage multiple tissues and organs. Chronic GVHD devastates the lives of up to 50% of patients who undergo an allogeneic hematopoietic stem cell transplant. GVHD is considered one of the main causes of morbidity (poor health) and late non-relapse mortality after stem cell transplant. The consequences are far-reaching, both in terms of the burden it can place on the individual’s physical and emotional well-being, as well as the broader socio-economic impact.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

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SOURCE: Sanofi