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news.Denmark-based Veloxis Pharmaceuticals has received orphan drug status by the US Food and Drug Administration (FDA) for its Envarsus XR (tacrolimus extended-release tablets).
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Envarsus XR, which received marketing authorization from the FDA on 10 July 2015, is indicated for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants.
Veloxis president and chief executive officer Dr William Polvino said: "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."
The orphan drug designation is granted by the FDA upon recognition that the prevalence of the US target patient population is 200,000 patients or less.
Envarsus XR is contraindicated in patients with known hypersensitivity to tacrolimus and the most common adverse reactions (incidence =10%) reported are diarrhea and increased blood creatinine.