The U.S. Food and Drug Administration (FDA) has informed Veloxis Pharmaceuticals A/S that the FDA still maintains that the exclusivity for Astagraf XL should require delays in the formal approval of Envarsus® XR.
The FDA has stated that it would be prepared to approve Envarsus XR for use only in patients transitioned from an immediate release formulation of tacrolimus to Envarsus XR, subject to Veloxis not seeking approval for de novo use of Envarsus until on or after July 19, 2016.
Envarsus XR is a once-daily extended-release tablet for prophylaxis of organ rejection in kidney transplant patients. Although Envarsus XR has been found to be safe and effective, the FDA 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 in July 2016.
Veloxis continues to disagree with the FDA’s position, and intends to present the merits of its case in support of final approval of Envarsus XR.