NDA Submitted for Envarsus in Kidney Transplant Prophylaxis

Veloxis announced  the submission of a New Drug Application (NDA) to the FDA for Envarsus (tacrolimus; formerly LCP-Tacro) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.

The NDA submission is based on the entire data set from the clinical development program that comprised 25 studies and enrolled over 1000 patients, including two pivotal clinical trials, studies 3001 and 3002.

Envarsus is an investigational drug that it is being developed as a once‐daily tablet version of tacrolimus using Veloxis' proprietary MeltDose technology. Tacrolimus is an immunosuppressant used for the prevention of transplant allograft rejection after organ transplantation.

Envarsus was granted Orphan Drug Designation on December 26, 2013.

For more information call (732) 321-3200 or visit Veloxis.com.