Veloxis A/S reports publication of ASERTAA trial in American Journal of Kidney Diseases of Envarsus XR in AfroAmerican renal translant patients.

Veloxis Pharmaceuticals A/S announced the publication of results of ASERTAA, a Randomized Prospective Crossover Pharmacogenetic Study of Immediate-Release Versus Extended-Release Tacrolimus in African American Kidney Transplant Recipients in the March 2018 issue of the American Journal of Kidney Diseases.

As previously reported, ASERTAA, a Phase IIIb study of Envarsus XR (tacrolimus extended-release tablets) was designed to compare the pharmacokinetics (PK) of Envarsus XR, a once-daily tacrolimus tablet, to generic twice daily tacrolimus immediate-release capsules in stable African-American renal transplant patients. The ASERTAA trial demonstrated that patients on Envarsus XR achieved therapeutic drug levels with a 30% lower peak concentration and 20% lower average dose compared to tacrolimus immediate-release regardless of genotype status. Importantly, patients expressing the CYP3A5 1 genotype on tacrolimus immediate-release reached a peak concentration as high as 26 ng/mL.

In June 2016, Veloxis announced that the FDA had approved label enhancements containing ethnicity-specific dosing and unique genotyping guidance for Envarsus XR based on the results of the ASERTAA study. Veloxis Pharmaceuticals Inc. Chief Scientific Officer Ulf Meier-Kriesche, M.D. said, "This is one of the largest pharmacogenetic studies of its kind, and the data suggest that African-American patients treated with Envarsus XR are able to reliably achieve adequate exposure to Tacrolimus without potentially toxic peak levels. For carriers of the CYP3A5 1 gene, achieving adequate immunosuppression with IR-Tac came at the cost of a 30% higher peak concentration. Patients on Envarsus XR did not experience the higher peaks, and the pharmacokinetic profile was consistent regardless of genotype. The study reinforces our belief that Envarsus XR is an effective therapy to optimize immunosuppression management in African-American transplant patients."

See- " Results of ASERTAA, a Randomized Prospective Crossover Pharmacogenetic Study of Immediate-Release Versus Extended-Release Tacrolimus in African American Kidney Transplant Recipients"- Jennifer Trofe-Clark, Daniel C. Brennan, Patricia West-Thielke, Michael C. Milone, Mary Ann Lim, Robin Neubauer, Vincenza Nigro, Roy D. Bloom'-DOI: https://doi.org/10.1053/j.ajkd.2017.07.01.