The CHMP recommends approval of Sanofi's Rezurock for the treatment of chronic GVHD

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the conditional marketing authorization of Sanofi's Rezurock (belumosudil). This medicine is intended for the treatment of chronic graft-versus-host disease (GVHD) in adults and children aged 12 years and older weighing at least 40 kg. This decision is based on efficacy and safety results from several clinical trials, including the ROCKstar study. Sanofi has reviewed a previous negative opinion, and the European Commission's final decision is expected soon.

Rezurock, a new selective ROCK2 inhibitor, is already approved in approximately 20 countries, including the United States and Canada. It is intended for patients who have exhausted other treatment options. Sanofi plans to conduct a post-approval study to confirm the results obtained. More than 17,000 patients have already been treated with Rezurock since its launch in 2021. The publication of this information underscores the importance of offering innovative solutions for complex diseases such as chronic GVHD.