FDA approves Envarsus XR for organ rejection in de novo kidney transplant.- Veloxis Pharma.

Veloxis Pharmaceuticals announced that the 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 centers 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 III 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). The primary endpoint of the study was a composite endpoint of treatment failure (biopsy-proven acute rejection or BPAR, graft failure, loss to follow up or death) that was evaluated after a 12-month treatment period to demonstrate the non-inferiority of Envarsus compared to Prograf. The treatment failure rate for Envarsus was 18.3% compared to 19.6% for Prograf.

Comment: Envarsus XR was approved by the FDA on 10 July 2015 for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants. Veloxis's original New Drug Application (NDA) for Envarsus XR sought approval for the de novo indication and was filed on 30 December 2013. FDA tentatively approved Envarsus XR for the de novo indication on 30 October 2014; however, final approval was blocked by the exclusivity of Astagraf XL which expired on 19 July 2016.