
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
Filed Under: Drug Discovery