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.
Envarsus® XR (tacrolimus extended-release tablets) – Important Safety Information
BOXED WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing serious infections and malignancies with ENVARSUS XR or other immunosuppressants that may lead to hospitalization or death
INDICATIONS AND USAGE
ENVARSUS XR is indicated for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants.
Limitation of Use: ENVARSUS XR extended-release tablets are not interchangeable or substitutable with other tacrolimus extended-release or immediate release products
ENVARSUS XR is contraindicated in patients with known hypersensitivity to tacrolimus.
WARNINGS AND PRECAUTIONS
Immunosuppressants, including ENVARSUS XR, increase the risk of developing lymphomas and other malignancies, particularly of the skin.
Post-transplant lymphoproliferative disorder (PTLD), associated with Epstein-Barr Virus (EBV), has been reported in immunosuppressed organ transplant patients.
Immunosuppressants, including ENVARSUS XR, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes.
ENVARSUS XR is not interchangeable or substitutable with tacrolimus immediate-release products or other tacrolimus extended-release products.
Avoid the use of live attenuated vaccines during treatment with ENVARSUS XR. Inactivated vaccines noted to be safe for administration after transplantation may not be sufficiently immunogenic during treatment with ENVARSUS XR.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with tacrolimus.
Most common adverse reactions (incidence ?10%) reported with ENVARUS XR are: diarrhea and blood creatinine increased.
For full Prescribing Information, see the US Package Insert and Medication Guide at www.envarsusxr.com