19 December 2018 - Veloxis Pharmaceuticals announced today that the U.S. FDA approved a new indication for Envarsus XR (tacrolimus extended-release tablets) to prevent organ rejection in de novo kidney transplant patients in combination with other immunosuppressants. 

This indication is commonly referred to as the de novo indication.

Envarsus XR was approved for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in 2015 and has already been used in the conversion setting in more than 90% of the transplant centres in the U.S. The approval for de novo use provides an important new treatment option for kidney transplant patients and providers, where significant unmet need currently exists.

The FDA’s approval is based on the Phase 3 clinical development program which was a randomized, double-blind, double-dummy, Phase III study in 543 de novo kidney transplant patients that demonstrated comparable efficacy and safety compared to twice-daily tacrolimus (Prograf).

Read Veloxis Pharmaceuticals press release