Astellas' Prograf (Tacrolimus) Approved in the U.S. as First Immunosuppressant to Prevent Lung Transplant Rejection Based on Real-World Evidence

Lung Transplantation (Image source: authorstream.com)

July 18, 2021 /BioonBIOON/ -- U.S. Food and Drug Administration (FDA) recently approved AstellasPrograf (Chinese Brand Name: Pulekefu, Generic Name: tacrolimus)A new use,Used in combination with other immunosuppressants for the prophylaxis of organ rejection in adult and pediatric patients undergoing lung transplantation.This approval is based on a non-interventional (observational) study, which providedReal-world evidence of efficacy (RWE).

In the United States, Prograf was initially approved for the prevention of organ rejection in liver transplant patients, and later approved for the prevention of organ rejection in kidney and heart transplant patients.Prograf is also frequently used in clinical practice for lung transplant patients.

This approval reflects: inFDAUnder the regulation, how a well-designed, non-interventional study based on fit-for-purpose real-world data (RWD) is considered adequate and well-controlled when compared to a suitable control.

Specifically, the non-interventional study supporting the approval of this new indication, with support from the U.S. Department of Health and Human Services (HHS), utilized real-world data (RWD) from the Scientific Registry of Transplant Recipients (SRTR). These data, collected from all lung transplant cases in the United States, were supplemented by the Death Master File from the U.S. Social Security Administration (SSA), which serves as a reliable repository for mortality data. The data showed that,Compared to the well-documented natural history of transplant recipients on no or minimal adjunctive immunosuppressive therapy, lung transplant patients treated with Prograf as part of a multidrug immunosuppressive regimen have significantly improved outcomes.

In addition to RWE from non-interventional studies, in other entitiesOrgan Transplantation... randomized controlled trials using Prograf provided confirmatory evidence of efficacy. Other ... from published studiesClinical TrialEvidence supports the independent contribution of Prograf as part of a multidrug immunosuppressive regimen.

Regarding medication use, Prograf should only be prescribed by physicians experienced in immunosuppressive therapy andOrgan transplantationprescribed by physicians experienced in management, patients receiving pharmacotherapy should be managed in facilities equipped with adequate laboratory and supportive medical resources. Prograf is associated with the development of lymphoma and other malignantTumor`associated with an increased risk of, and with`Bacteria、associated with increased susceptibility to viruses, fungi, and protozoa, including opportunistic infections.

In China,Prograf (Pulekefu, Tacrolimus Capsules and Injection)Indications: Prophylaxis of graft rejection following liver or kidney transplantation; treatment of graft rejection following liver or kidney transplantation that is refractory to other immunosuppressive therapy.

Additionally, there is also aTacrolimus Extended-Release Capsules, indications are: prophylaxis of graft rejection following kidney transplantation, prophylaxis of graft rejection during the maintenance phase following liver transplantation, and treatment of graft rejection refractory to other immunosuppressive agents following kidney or liver transplantation.

Original Source:FDA Approves New Use of Transplant Drug Based on Real-World Evidence