Veloxis Pharmaceuticals A/S, a specialty pharmaceutical company, announced the US launch of Envarsus XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from immediate release tacrolimus products to once-daily Envarsus XR.
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. Envarsus XR has Orphan Drug status in the US and has been issued a unique reimbursement J-code by the Centers for Medicare and Medicaid Services (CMS) for 2016 onwards. Veloxis will be marketing and selling Envarsus XR through its own dedicated specialty sales force in the US.
"This is an important milestone for our company and we are excited about providing an option to kidney transplant patients who are seeking a switch from their current immunosuppressant regimen," said Bill Polvino, president and chief executive officer of Veloxis.
"Our sales force is now out in the field detailing transplant physicians about the potential benefits of Envarsus XR and our patient support services, for which we strive to be best-in-class, are now active. We expect prescription growth to be gradual and steady as existing transplant recipients are converted to Envarsus XR and we look forward to communicating the progress of our launch in the coming quarters."
Envarsus has received marketing authorisation in the EU for prophylaxis of organ rejection in kidney and liver transplant recipients. Veloxis plans to commercialise Envarsus XR in the US through its own sales force and in the EU through its partnership with Chiesi Farmaceutici SpA.