The first immunosuppressant approved for this population

The FDA has approved tacrolimus in combination with other immunosuppressants for the prevention of organ rejection in adults and kids receiving lung transplantation. It is the first immunosuppressant drug approved for adults and children, the FDA noted in its statement.

The immunosuppressant is already approved for the prevention of organ rejection in liver, kidney, and heart transplants and has been used clinically for patients receiving lung transplant.

An observational study provided real-world evidence (RWE) showing its efficacy. “Specifically, the non-interventional study supporting approval for this new indication used [real-world data] from the U.S. Scientific Registry of Transplant Recipients (SRTR), supported by the Department of Health and Human Services. The data were collected on all lung transplants in the U.S. and were supplemented by information from the Social Security Administration’s Death Master File as a trusted repository of mortality data,” The FDA reported. “A dramatic improvement in outcomes was observed among lung transplant patients receiving [tacrolimus] as part of their immunosuppression medications compared to the well-documented natural history of a transplanted drug with no or minimal immunosuppressive therapy.”

The agency also noted that along with the observational study data, other randomized controlled trials confirmed the effectiveness of tacrolimus in other solid organ transplant settings.

Only physicians who are experienced in immunosuppressive therapy and management of organ transplant should prescribe tacrolimus “and patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources,” the FDA noted.

Side effects of the treatment include an “increased risk of developing lymphoma and other malignancies and [tacrolimus] is associated with increased susceptibility to bacterial, viral, fungal, and protozoals, including opportunistic infections,” the agency noted.

Tacrolimus is marketed as Prograf by Astellas Pharma US, Inc., which was granted this approval.

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 633

Topic ID: 630,633,633,730,138,925