FDA Expands Approval Sanofi’s Thymoglobulin for the Prevention of Kidney Transplant Rejection
Sanofi received FDA approval for Thymoglobulin for use in conjunction with concomitant immunosuppression in the prevention of acute rejection of kidney transplants.
Clinical studies revealed a composite endpoint rate within 12 months post transplantation of 25.1 percent in the Thymoglobulin group compared with 36 percent in the IL2RA group (basiliximab or daclizumab-receptor antagonists).
The most frequent adverse reactions seen in these clinical trials (more than 25 percent of patients receiving Thymoglobulin) include: leukopenia, hyperkalemia, urinary tract infection and pyrexia.
Thymoglobulin was approved by the FDA in 1998 for the treatment of renal transplant acute rejection.