Trials of once-daily Envarsus® XR, an investigational drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated that a lower dose in African-American patients is sufficient for therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus, according to Veloxis.
Veloxis is seeking an order requiring the FDA to grant final approval to Envarsus® XR. The U.S. District Court for the District of Columbia set a schedule that enabled briefing to be completed in the pending case by March 3. While Veloxis expects the matter to be resolved by the middle of this year, it is possible that delays may occur, BioSpace.com notes. There can be no assurance that Veloxis will be successful in its action against the FDA.
Veloxis is preparing for launch of Envarsus® XR in the US in the second half of the year, either for the full indication that would include both de novo and conversion kidney transplant patients or for a more narrow initial indication in the conversion setting.