FDA: New Indication for Thymoglobulin

The FDA has approved Thymoglobulin [anti-thymocyte globulin (rabbit)] for use with concomitant immunosuppression in the prophylaxis, or prevention, of acute rejection in kidney transplant patients.

The approval was based on 2 randomized studies comparing Thymoglobulin to interleukin-2 receptor antagonists (basiliximab or daclizumab) in decreased donor kidney transplant patients.
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In the first study, those taking Thymoglobulin showed a significantly lower incidence of the treatment failure within 12 months following transplantation compared with patients in the basiliximab group.

In the second study, patients receiving Thymoglobulin showed a lower incidence of treatment failure than those taking daclizumab.

The most frequent adverse events in the clinical trials were leukopenia, hyperkalemia, urinary tract infection, and pyrexia.

—Michael Potts

Reference:

Sanofi receives FDA approval of Thymoglobulin® for the prevention of acute kidney transplant rejection [press release]. Bridgewater, New Jersey. April 24, 2017. http://www.news.sanofi.us/2017-04-24-Sanofi-Receives-FDA-Approval-of-Thymoglobulin-R-for-the-Prevention-of-Acute-Kidney-Transplant-Rejection.