Danish drugmaker Veloxis Pharmaceuticals got new indication for its Envarus XR tablets to prevent organ rejection in de novo kidney transplant patients in combination with other immunosuppressants.
The U.S. Food & Drug Administration (FDA) approved a new indication for Envarsus XR 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 company noted in the press release announcing the new indication. Veloxis points out that the approval for de novo use provides an important new treatment option for kidney transplant patients and providers, where significant unmet need currently exists.
Ulf Meier-Kriesche, Chief Scientific Officer at Veloxis Pharmaceuticals, said: “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.”
The FDA’s approval is based on the Phase 3 study in 543 de novo kidney transplant patients, in which it showed comparable efficacy and safety compared to twice-daily tacrolimus (Prograf).
The primary endpoint of the study was a composite endpoint of treatment failure, including death, that was evaluated after a 12-month treatment period to demonstrate the non-inferiority of Envarsus (18.3%) compared to Prograf (19.6%).
Craig A. Collard, Chief Executive Officer of Veloxis Pharmaceuticals A/S noted 200,000 patients living with a kidney transplant and a significant number of them who converted to Envarsus XR since December 2015. “With the addition of the de novo indication, the roughly 16,000 adult patients who receive a kidney transplant each year will now have access to Envarsus XR following surgery. This approval is another example of Veloxis’s commitment to transplant and the patients, donors and providers that make it all possible,” he said.