Envarsus XR Approved for New de novo Indication

Veloxis announced that the Food and Drug Administration (FDA) has approved Envarsus XR (tacrolimus extended-release) tablets to prevent organ rejection in de novo kidney transplant patients in combination with other immunosuppressants (“de novo indication”).

Envarsus XR, a calcineurin inhibitor, was initially approved in 2015 for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations. The de novo indication offers a new treatment option for kidney transplant patients and providers. 

The approval was supported by data from a randomized, double-blind, double-dummy Phase 3 study (N=543) that evaluated de novo kidney transplant patients. The primary endpoint was a composite endpoint of failure (biopsy-proven acute rejection, graft failure, loss of follow-up or death) evaluated after 12 months of treatment. The data showed comparable efficacy and safety compared with twice-daily tacrolimus (Prograf; Astellas Pharma) as evident by 18.3% treatment failure rate with Envarsus XR vs 19.6% for Prograf. 

“Today marks the beginning of an exciting new chapter in immunosuppression. Kidney transplant patients will now be able to receive a refined and simplified gold standard treatment regimen from the beginning of the kidney transplant journey,” said Ulf Meier-Kriesche, MD Chief Scientific Officer at Veloxis Pharmaceuticals, Inc.

Envarsus XR is available as 0.75mg, 1mg, and 4mg extended-release tablets in 30- and 100-count bottles.

For more information call (732) 321-3200 or visit EnvarsusXR.com.