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Veloxis wins Orphan Drug status

Veloxis’ Envarsus XR has been awarded FDA’s Orphan Drug status. It could lead to tax benefits and higher sales prices, says an analyst, stressing, however, that the company remains strapped for cash.

Foto: Colourbox

Denmark’s Veloxis ended last week with a bit of good news, as it announced that FDA has granted Orphan Drug status for its drug Envarsus XR  for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus.

"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. We now look forward to making Envarsus XR available to conversion patients by the end of 2015," says William Polvino, M.D., president and chief executive officer of Veloxis, according to a press release.

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