Veloxis announced that the FDA has granted Orphan Drug designation to Envarsus (tacrolimus; formerly LCP-Tacro) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.
The Orphan Drug designation is based on a plausible hypothesis that Envarsus may be clinically superior to currently marketed tacrolimus products for the prevention of kidney transplant rejection.
Earlier this year Veloxis announced results from its LCP-Tacro Phase 3 clinical trial which demonstrated that patients can be converted from twice-daily Prograf to once-daily LCP-Tacro.
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.
For more information call (732) 321-3200 or visit Veloxis.com.