New data for Envarsus XR (tacrolimus extended release) in African-American Transplant patients- Veloxis Pharma

Veloxis Pharmaceuticals has announced that once-daily Envarsus XR (tacrolimus extended-release), for the prevention of organ rejection in adult kidney transplant patients, demonstrated that a lower dose of once-daily Envarsus XR in African-American kidney transplant patients is sufficient to achieve therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus. The overall PK differences (increased absorption, lower peak blood concentrations, less peak-to-trough fluctuation in blood levels) between Envarsus XR and IR-Tac capsules seen previously in studies of kidney transplant recipients were also confirmed in this exclusively African-American patient population.

In addition, the optimal conversion ratio for once-daily extended release Envarsus XR was shown to be approximately 20% lower than the total IR-Tac. Finally peak tacrolimus concentration was reduced 30% for patients on Envarsus while intra-day fluctuation was reduced 50%. These data, which are from one of the largest trials of tacrolimus pharmacokinetics in African-American kidney transplant patients conducted to date, were presented at the American Transplant Congress.

Comment: Veloxis Pharma is currently involved in court action in the US: The FDA has determined that the period of statutory exclusivity granted to another extended-release tacrolimus product, Astagraf XL, blocks Envarsus XR from being sold in the United States until that exclusivity period expires (July 2016) as previously announced by the Company on October 31, 2014. As a result, Veloxis Pharmaceuticals has filed an action in federal district court for the District of Columbia against the FDA, seeking an order requiring it to grant final approval to Envarsus XR.