Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that Envarsus® XR was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus. Envarsus® XR received marketing authorization from the FDA on July 10, 2015.
"We view Orphan Drug status as the FDA's recognition of the differentiated profile and the unique 'switch' indication of Envarsus® XR compared to other tacrolimus products," said William Polvino, M.D., president and chief executive officer of Veloxis. "We now look forward to making Envarsus® XR available to conversion patients by the end of 2015."
Orphan drug designation is designed is to encourage the development of drugs that may provide significant benefit to patients suffering from rare diseases. The designation is granted by the FDA upon recognition that the prevalence of the U.S. target patient population is 200,000 patients or less. Orphan drug designation entitles Veloxis to a waiver of the FDA prescription drug user fees for Envarsus® XR as well as for potential tax incentives. Additionally, U.S. data exclusivity protection may be extended for up to seven years.