Friday, October 2, 2015

Envarsus XR granted FDA orphan drug designation for prophylaxis of organ rejection in kidney transplant patients

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 fromimmediate-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 thedifferentiated 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 forwardto making Envarsus® XR available to conversion patients by the end of 2015."

Orphan drug designation is designed is to encourage the developmentof 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 200,000patients or less. Orphan drug designation entitles Veloxis to a waiver of the FDA prescription drug user fees for Envarsus® XR aswell as for potential tax incentives. Additionally, U.S. dataexclusivity protection may be extended for up to seven years.


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