Veloxis announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Envarsus XR (tacrolimus extended-release) tablets for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants.

The sNDA submission was supported by data from the phase 3 LCP-Tacro 3002 study (N>500) that evaluated the safety and efficacy of Envarsus XR vs immediate-release tacrolimus capsules for the prevention of acute allograft rejection in de novo adult kidney transplant recipients. The primary endpoint was incidence of treatment failures within 12 months, defined as death, graft failure, biopsy-proven acute rejection, or lost to follow-up. 

In the study, Envarsus XR proved non-inferior to immediate-release tacrolimus as seen by treatment failure rates of 18.3% vs 19.6%, respectively. 

Envarsus XR was initially approved in July 2015 for organ rejection prophylaxis in kidney transplant patients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Its NDA for the new indication, filed in October 2014, was tentatively approved by the FDA; the final approval was blocked by the exclusivity of Astagraf XL

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

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