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New Drug Application Submitted for Once-Daily Tacrolimus (Envarsus) in Kidney Transplant Recipients

Immunosuppressive treatment helps prevent graft rejection (December 30)

A New Drug Application (NDA) has been submitted to the FDA seeking approval for the marketing and sale of Envarsus (once-daily tacrolimus, Veloxis Pharmaceuticals) for the prevention of organ rejection in kidney transplant recipients. The submission was based on data from 25 clinical studies involving more than 1,000 patients, including two pivotal trials.

In the pivotal studies, Envarsus met the primary endpoint of demonstrating comparable efficacy and safety versus twice-daily tacrolimus (Prograf, Astellas Pharma). In the largest study, Envarsus was shown to have a primary efficacy failure rate of 18.3% compared with 19.6% for Prograf.

Envarsus was granted orphan drug status by the FDA for the prophylaxis of rejection in kidney transplant recipients.

Tacrolimus is a leading immunosuppressive drug used for the prevention of transplant allograft rejection after organ transplantation. Envarsus is an investigational drug that is being developed as a once-daily tablet version of tacrolimus. Transplant patients need to maintain a minimum blood level of tacrolimus for the prevention of transplant allograft rejection.

Source: Veloxis Pharmaceuticals; December 30, 2013.

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