Date: 2015-06-24
Type of information: Results
phase: 3
Announcement: results
Company: Veloxis Pharmaceuticals (Denmark)
Product: Envarsus® (previously LCP-Tacro™) (tacrolimus)
Action
mechanism: immunosuppressive agent. 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.
Disease: prevention of organ rejection in adult kidney transplant patients
Therapeutic area: Transplantation
Country:
Trial details:
Latest
news: * On June 24, 2015, Veloxis Pharmaceuticals announced top-line results of the ASTCOFF study, A STeady-state Pharmacokinetic COmparison Of all FK-506 Formulations, demonstrating that once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, achieved differentiated pharmacokinetics (PK) when compared to twice-daily tacrolimus (Prograf®) or a once-daily tacrolimus product (Astagraf XL®). ASTCOFF is the first pharmacokinetic study to compare all three of these branded formulations of tacrolimus and is a two-sequence, three-period crossover study, designed to compare the steady-state PK profiles of Envarsus XR tablets (Veloxis Pharmaceuticals Inc., New Jersey, USA), Astagraf XL (Astellas Pharma US, Inc., Northbrook, IL) capsules administered once-daily and Prograf capsules (Astellas Pharma US, Inc., Northbrook, IL) administered twice-daily in stable renal transplant patients. Patients were dosed with each drug for seven days and blood samples were obtained over 24 hours to obtain pharmacokinetic data. This study confirmed previously published data for Envarsus and showed greater bioavailability (p<0.0001) and a flatter PK profile characterized by lower peak-to-trough fluctuation (p<0.001) and delayed time to peak concentrations of 6 hrs (p=<0.001) compared to both Prograf and Astagraf. At equivalent exposure, Envarsus achieves at least a 30% dose reduction requirement and a substantively lower peak blood concentration (p=<0.005) compared to the two comparator products.
