Veloxis Pharma submits NDA for Envarsus in kidney transplant recipients

Denmark’s Veloxis Pharmaceuticals (OMX: VELO) has submitted a New Drug Application to the US Food and Drug Administration seeking approval for the marketing and sale of Envarsus (once-daily tacrolimus; formerly LCP-Tacro) for the prevention of organ rejection in kidney transplant recipients.

The submission is based on the entire data set from the company's clinical development program that comprised 25 studies and enrolled over 1,000 patients, including two pivotal clinical trials, studies 3001 and 3002. In the two pivotal trials, Envarsus given once-daily met the primary endpoint of demonstrating comparable efficacy and safety compared to twice-daily tacrolimus (Prograf, Astellas Pharma).

In the largest study, Study 3002, Envarsus was shown to have a primary efficacy failure rate of 18.3% versus 19.6% with Prograf therapy. The differences between the treatments was well-within the pre-defined 10% non-inferiority margin. The study was conducted under a Special Protocol Agreement with the FDA.  Envarsus has been granted Orphan Drug status by the FDA for prophylaxis of rejection for kidney transplant recipients.