Veloxis Pharmaceuticals A/S announced the U.S. Food and Drug Administration (FDA) accepted for standard review the company’s New Drug Application (NDA) for Envarsus for the prevention of organ rejection in adult kidney transplant patients. Envarsus is Veloxis’ once-daily tacrolimus based on the company’s proprietary MELTDOSE technology.

 

Key points:

• The FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of Oct. 3
• The NDA was submitted to the FDA on Dec. 30, 2013
• The NDA is based on two Phase 3 studies, 3001 and 3002, in which Envarsus demonstrated non-inferiority compared to twice daily tacrolimus (Prograf) based on a composite endpoint of treatment failure at one year
• The clinical program comprised 25 studies and enrolled over 1,000 patients
• Envarsus is a once-daily formulation of tacrolimus that demonstrates a smoother pharmacokinetic profile and enables lower dosing to maintain therapeutic blood levels compared to twice-daily tacrolimus
• Envarsus received Orphan Drug Designation by the FDA for prophylaxis of organ rejection in patients receiving allogeneic kidney transplants