FDA Accepts Veloxis Pharmaceuticals' Envarsus NDA For Kidney Transplant Patients

Veloxis Pharmaceuticals announced in a press release that the Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Envarsus. The new drug is indicated for kidney transplant patients to prevent organ rejection. Submitted to the FDA on December 30, 2013, the NDA is up for standard review with a response due by October 30, 2014. William Polvino, M.D., chief executive officer of Veloxis, said about the clinical trials that led to the FDA’s application acceptance, "We look forward to continuing to develop this new treatment option for transplant patients for whom there remains significant unmet medical needs."

Kidney Transplantation

Kidneys clean the blood. A kidney transplant surgically installs a new kidney in a person’s body. The healthy kidney is placed in the abdomen and connected to the arteries and veins, allowing the patient to give up dialysis. Kidney transplant patients must take anti-rejection drugs for the remainder of their lives so the foreign kidney remains functional. These immunosuppressant drugs act to dampen the immune system so it does not attack the foreign kidney. The drugs have a downside, as suppressing the immune system leaves the patient open to other attacks.

Envarsus

Envarsus (tacrolimus) is a prophylactic or preventative drug to prevent organ rejection. Envarsus, formerly known as LCP-Tacro, is an immunosuppressive drug taken once daily, instead of twice daily. Dr. Suphamai Bunnapradist, M.D., Professor of Medicine and Director of Kidney Transplant Research at the Ronald Reagan Medical Center and David Geffen School of Medicine at UCLA, said, "This is important because once-daily dosing should be beneficial for kidney transplant patients who are on life-long complex therapy."

The new formulation offers better pharmacokinetic performance and bioavailability. Patients and their physicians must monitor the concentration of immunosuppressive drugs in the blood. A minimum concentration is important to prevent rejection, but too much causes excessive side effects like infections and high blood pressure. Envarsus’ drug profile may make the dosing and monitoring process easier. Envarsus utilizes the company’s MeltDose technology, a drug delivery system.

The FDA accepted the NDA application based on the strength of clinical studies, 25 studies and over 1,000 people. Envarsus performed as well as twice-daily doses of tacrolimus. Due to the rarity of the condition and the pressing need, the FDA gave Envarsus Orphan Drug status.