Denmark-based Veloxis Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its Envarsus XR (tacrolimus extended-release tablets) to treat kidney transplant patients.
Approval has been granted for 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 that was developed for once-daily dosing with flatter pharmacokinetics and enhanced bioavailability compared to twice-daily tacrolimus.
Veloxis Pharmaceuticals CEO Bill Polvino said: "This is a proud moment for everyone at Veloxis and we appreciate the hard work by our study investigators and the participation of the patients in our studies.
"We are now aggressively moving forward with completing the build-up of our commercial organisation as planned, including the recruitment of our sales force who will promote Envarsus XR to transplant physicians in the US."
Approval was based on the data of Envarsus XR’s two Phase III trials and several Phase II trials in kidney transplant recipients.
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By GlobalDataIn the studies, Envarsus XR dosed once-daily showed significantly higher bioavailability and flatter PK profile, compared with transplant drug Prograf (immediate release tacrolimus) dosed twice-daily.
Envarsus XR also obtained orphan drug designation in the US.
In the EU, Envarsus (tacrolimus prolonged-release tablets) received marketing approval for prophylaxis of organ rejection in kidney and liver transplant recipients.
Through its own sales force, the company plans to commercialise tablets in the US, and through its partner Chiesi Farmaceutici in the EU.
