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news.The US Food and Drug Administration (FDA) has granted approval for Veloxis Pharmaceuticals' Envarsus XR 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.
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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 marketing approval is based on the review of two Phase III trials and several Phase II trials in kidney transplant recipients.
The company noted that in all of the clinical trials, Envarsus XR dosed once daily showed significantly higher bioavailability and a flatter PK profile, compared to the current leading transplant drug, Prograf (immediate release tacrolimus), dosed twice-daily.
Veloxis chief executive officer Bill Polvino said: "We are now aggressively moving forward with completing the buildup of our commercial organization as planned, including the recruitment of our sales force who will promote Envarsus XR to transplant physicians in the US."
The company expects to make Envarsus XR available to patients in the US and their physicians in the fourth quarter of this year.