Sanofi's latest analysis of Rezurock can inform future research, company says

After Kadmon scored its first FDA approval last summer, it took Sanofi less than two months to swoop in for a $1.9 billion purchase of the New York City biotech and its drug Rezurock to treat chronic graft-versus-host disease.

Seven months later, Sanofi has released pooled data from two trials of Rezurock that show a strong correlation between certain organ responses and improvements in patient-reported outcomes (PROs).

The clinically meaningful changes in PROs were reported in the skin, mouth, eye, lung, upper gastrointestinal and overall measures, Sanofi says. The data support the use of PROs for response assessment in clinical trials of cGVHD therapies, according to the company.

The data “reinforce the importance of patient-reported outcome measures by showing their correlation to clinical response,” Jonathan Ieyoub, head of Sanofi US Rezurock Medical, said in a release.

“Knowing the impact that chronic graft-versus-host disease has on patients, the results add support for use of patient-reported outcomes to assess responses in clinical care,” he added.

Rezurock’s FDA nod came in July of last year—six weeks ahead of schedule. The drug, a first-in-class ROCK2 inhibitor, has shown to be effective in treating those who have not had success with steroids. GVHD occurs when donor cells from a transplant mount an immune response against a patient’s own tissues and organs.

Upon its approval, analysts at Cantor Fitzgerald pegged Rezurock’s peak sales potential at $500 million.

Adding Rezurock has bolstered Sanofi’s existing transplant portfolio, which includes hematopoietic stem cell mobiulizer Mozobil and immunosuppressive agent Thymoglobulin. The drugs chalked up (PDF) sales of €583 million ($635 million) last year, an increase of 12% from 2020.

Meanwhile, Rezurock generated an additional €20 million in sales for Sanofi after completion of the purchase of Kadmon was finalized on November 9.