Veloxis Pharmaceuticals was granted Orphan Drug status by the FDA for Envarsus for prevention of organ rejection in patients receiving allogenic kidney transplants. Envarsus is a once-daily formulation of tacrolimus employing the company's MeltDose technology.
Orphan drug designation is granted for potential treatments that target a patient population of 200,000 or less. For Envarsus, the designation is based on the potential that Envarsus may be clinically superior to currently marketed tacrolimus products in the U.S. The designation entitles Veloxis to a waiver of the FDA prescription drug user fees for Envarsus, as well as data exclusivity protection, which may be extended for as many as seven years upon approval.
"We have developed Envarsus with the goal of improving the care and reducing the treatment burden of patients who have undergone a kidney transplant," said William Polvino, M.D., president and chief executive officer of Veloxis. "FDA recognition of the potential of Envarsus as the only once-daily tacrolimus to be designated an Orphan Drug highlights these potential benefits. We continue to work on our New Drug Application (NDA), which we expect to submit by the end of 2013."