Policy & Regulation
Veloxis Submits sNDA to US FDA for De Novo Indication for Envarsus XR
12 March 2018 - - Copenhagen, Denmark-based biopharmaceutical company Veloxis Pharmaceuticals A/S has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration seeking a new indication for Envarsus XR (tacrolimus extended-release tablets) for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants, commonly referred to as the de novo indication, the company said.
The sNDA is based on data from multinational phase 3 study LCP-Tacro 3002, which evaluated the safety and efficacy of Envarsus XR compared to immediate-release tacrolimus capsules for the prevention of acute allograft rejection in over 500 de novo adult kidney transplant recipients.
The primary endpoint was the incidence of treatment failures within 12 months. Treatment failure was a composite endpoint that included death, graft failure, biopsy-proven acute rejection or lost to follow-up.
Results showed treatment failure rates of 18.3% for the Envarsus XR group and 19.6% for the immediate-release tacrolimus capsules treatment group, demonstrating Envarsus XR as non-inferior to immediate-release tacrolimus capsules.
Veloxis is focused on identifying, developing, and commercializing meaningful products in transplantation and adjacent therapies utilizing its proprietary drug delivery technology, Meltdose.
The company is actively seeking business development and licensing targets within the areas of transplantation and adjacent specialties, and therapeutics for rare or severe disease for which chronic therapy is initiated in the large hospital setting.