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Pharmaceuticals / Submissions and Approvals

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

April 26, 2017

Sanofi has received FDA approval for Thymoglobulin for use in conjunction with immunosuppression in the prevention of acute rejection of kidney transplants.

The approval was based on two studies comparing Thymoglobulin to interleukin-2 receptor antagonists (IL2RA: basiliximab or daclizumab) in kidney transplant recipients.  The first study showed a significantly lower incidence of treatment failure. The second study was in kidney transplant patients at high immunological risk of rejection. The patients received either Thymoglobulin or daclizumab and also showed a lower incidence of treatment failure.

The most frequent adverse reactions seen in the clinical trials (in more than 25 percent of patients) included leukopenia, hyperkalemia, urinary tract infection and pyrexia.

Thymoglobulin was originally approved by the FDA in 1998 for the treatment of renal transplant acute rejection.

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