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# Sanofi Gains Approval for Kidney Transplant Rejection Therapy
- URL: https://www.fdaweb.com/sanofi-gains-approval-for-kidney-transplant-rejection-therapy/
- Published: 2017-04-24T12:00:00.000Z
- Updated: 2026-09-14T22:19:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138511

FDA has approved Sanofi’s Thymoglobulin \[anti-thymocyte globulin (rabbit)\], for use in conjunction with concomitant immunosuppression to prevent acute rejection in patients receiving a kidney transplant. Approval was based on data from two randomized multicenter studies comparing Thymoglobulin to interleukin-2 receptor antagonists (il2ra:basiliximab or daclizumab) in deceased donor kidney transplant recipients. “The first study in kidney transplant patients (n=278) at increased risk of acute rejection or delayed graft function showed 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 following transplantation in the Thymoglobulin group compared to patients in the basiliximab group (25% versus 38%; p=0.02),” the company says.

  
The second study was an investigator-sponsored study in 230 kidney transplant patients who were at high immunological risk for rejection. Patients received either Thymoglobulin or daclizumab and also showed a lower incidence of treatment failure as measured by the composite endpoint 12 months following transplantation (25% versus 34%), Sanofi says.