FDA approves Envarsus XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant- Veloxis Pharma

Veloxis Pharmaceuticals A/S announced FDA approval of Envarsus XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR. Veloxis expects Envarsus XR to be available to patients in the United States and their physicians in 4Q2015.

Envarsus XR is an extended release formulation of tacrolimus designed for once-daily dosing, with flatter pharmacokinetics and greater bioavailability compared to twice-daily tacrolimus. The FDA marketing approval is based on the review of two Phase III trials and several Phase II trials in kidney transplant recipients. In all of the clinical trials, Envarsus XR dosed once daily demonstrated significantly higher bioavailability and a flatter PK profile, compared to the current leading transplant drug, Prograf (immediate release tacrolimus), dosed twice-daily.

Comment: Veloxis plans to commercialize Envarsus XR in the U.S. through its own sales force and in the EU through its partnership with Chiesi Farmaceutici SpA. Envarsus XR received tentative approval by the FDA in October 2014 subject to expiry of exclusivity of Astagraf XL. It was approved in the EU in July 2014.