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Envarsus XR News
Posted 8 Mar 2016 by Drugs.com
TUESDAY, March 8, 2016 – Scientists have found new clues that help explain what's going wrong in the immune systems of people with lupus – insight they hope will lead to new therapies, or help guide current treatment choices. Lupus has several forms, but the most common is systemic lupus erythematosus (SLE). In SLE, the immune system mistakenly produces antibodies against the body's own tissue. The onslaught can have widespread effects, damaging the skin, joints, heart, lungs, kidneys and brain, according to the Lupus Foundation of America. The disease mostly strikes women, usually starting in their 20s or 30s, the foundation says. In the new study, the researchers found evidence that in people with lupus, some of the immune system's "B cells" mature the wrong way – so that they promote inflammation instead of fighting it. The findings, published online March 8 in the journal ... Read more
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FDA Approves Envarsus XR (tacrolimus) for Prevention of Organ Rejection in Kidney Transplant Patients
Posted 24 Jul 2015 by Drugs.com
Hørsholm, Denmark, July 10, 2015 – Veloxis Pharmaceuticals A/S (OMX: VELO) today announced U.S. Food and Drug Administration (FDA) approval of Envarsus XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR. Veloxis expects Envarsus XR to be available to patients in the United States and their physicians in 4Q 2015. Envarsus XR is an extended release formulation of tacrolimus designed for once-daily dosing, with flatter pharmacokinetics and greater bioavailability compared to twice-daily tacrolimus. The FDA marketing approval is based on the review of two Phase III trials and several Phase II trials in kidney transplant recipients. In all of the clinical trials, Envarsus XR dosed once daily demonstrated significantly higher ... Read more