Sanofi announced that the Food and Drug Administration (FDA) has approved Thymoglobulin (anti-thymocyte globulin [rabbit]) injection for use with concomitant immunosuppression in the prophylaxis of acute rejection in patients receiving a kidney transplant.
The FDA approval was supported by data from two randomized multicenter studies evaluating Thymoglobulin vs. interleukin-2 receptor antagonists (eg, basiliximab or daclizumab) in deceased donor kidney transplant recipients. The first study (n=278) showed that kidney transplant patients at increased risk of acute rejection or delayed graft function had a significantly lower incidence of the treatment failure as measured by a composite endpoint (biopsy-proven acute rejection, graft loss, death or lost to follow-up) within 12 months after transplantation in the Thymoglobulin group vs. patients in the basiliximab group (25% vs. 38%; P=0.02).
The second study (n=230) showed that kidney transplant patients at high immunological risk of rejection who received Thymoglobulin had a lower incidence of treatment failure vs. daclizumab as measured by the composite endpoint within 12 months following transplantation (25% vs. 34%). The between-treatment group difference was estimated to be –9% (95% CI: –19.9 to 3.6) showing non-inferiority of Thymoglobulin vs. daclizumab.
A pooled analysis of the two studies showed a composite endpoint rate within 12 months after transplantation of 25.1% in the Thymoglobulin group vs. 36% in the interleukin-2 receptor antagonists group. The between-treatment group difference was estimated at –10.9% showing superiority of Thymoglobulin for prophylaxis of acute rejection.
Thymoglobulin was originally approved for the treatment of renal transplant acute rejection in 1998. It is available as single-use 10mL vials containing 25mg of anti-thymocyte globulin as a lyophilized powder.
For more information call (800) 633-1610 or visit Thymoglobulin.com.