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Pharmaceuticals / Submissions and Approvals

FDA Expands Approval Sanofi’s Thymoglobulin for the Prevention of Kidney Transplant Rejection

April 28, 2017
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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.

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