The US Food and Drug Administration (FDA) has granted Orphan Drug status to specialty pharmaceutical company, Veloxis Pharmaceuticals A/S's Envarsus XR for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus. Envarsus XR received marketing authorisation 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 US 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, US data exclusivity protection may be extended for up to seven years.
Most common adverse reactions (incidence =10 per cent) reported with Envarus XR are: diarrhea and blood creatinine increased.
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. Envarsus (tacrolimus prolonged-release tablets) has received marketing authorisation in the EU for prophylaxis of organ rejection in kidney and liver transplant recipients. In the US, Envarsus, known as Envarsus XR (tacrolimus extended-release tablets), is approved for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations. Veloxis plans to commercialise Envarsus XR in the US through its own sales force and in the EU through its partnership with Chiesi Farmaceutici SpA.