Sanofi says CHMP issues negative opinion on MAA for Rezurock

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a negative opinion on the marketing authorisation application for Rezurock for the third-line treatment of adults and pediatric patients with chronic graft-versus-host disease. Sanofi (SNY) will seek a re-examination of the CHMP opinion. cGVHD is a life-threatening complication that devastates the lives of up to 50% of patients who undergo a stem cell transplant. cGVHD is considered one of the main causes of morbidity and late non-relapse mortality after stem cell transplant. “We are disappointed by the negative CHMP opinion for Rezurock in the EU and remain committed to serving the transplant patient community,” said Olivier Charmeil, Executive Vice President, General Medicines at Sanofi. “Sanofi is confident in the body of clinical and real-world evidence that underscores Rezurock’s consistent efficacy and well-established safety profile for treating third-line chronic graft-versus-host disease. We will continue to work closely with the European Medicines Agency with the aim of bringing this treatment to patients in the EU who are waiting.”