Sanofi obtains FDA go-ahead for kidney transplant drug

Thymoglobulin is intended for use in conjunction with standard immunosuppressive therapy following kidney transplants.
Thymoglobulin is intended for use in conjunction with standard immunosuppressive therapy following kidney transplants. | File photo

With kidney disease ranking in the nation’s top 10 causes of death, Sanofi recently announced a breakthrough with FDA approval of its branded Thymoglobulin for boosting immunosuppression for patients to prevent rejection following kidney transplants.

The U.S. Food and Drug Administration’s authorization represents a benchmark, according to Sanofi: 468,000 individuals nationwide are on dialysis to address kidney failure, with a substantial number -- approximately 100,000 -- awaiting transplant operations.

"Thymoglobulin has been a well-established medication used in kidney transplantation for nearly 20 years, and this FDA approval is an important milestone for the transplant community," said Dr. Daniel Brennan, who serves as director of transplant nephrology at the Barnes-Jewish Hospital of Washington University School of Medicine. "Transplant rejection can be particularly discouraging for patients. The use of Thymoglobulin beginning just prior to transplantation may be an important step to ensuring a successful kidney implantation."

Kidney disease is the ninth-leading cause of death in the U.S. Thymoglobulin is intended for use in conjunction with standard immunosuppressive therapy following kidney transplants.

Dr. David Meeker, who is an executive vice president and head of Sanofi Genzyme, the company’s specialty care global business branch that distributes the drug, said the firm has been actively involved in the kidney transplant community for many years.

“This FDA approval of Thymoglobulin for prophylactic use underscores our continued commitment to patients and their caregivers who will be receiving a potentially life-saving kidney transplant,” Meeker said, adding that Sanofi continues to work on medication development to combat life-threatening and debilitating illnesses.