Organ Rejection Prophylaxis

Imbruvica Approved for the Treatment of Chronic GVHD

By August 02, 2017

This marks the first FDA-approved treatment for cGVHD.

Amneal Introduces New Strength of Thiotepa with Tepadina

By April 27, 2017

Tepadina, an alkylating agent, is indicated to reduce the risk of graft rejection when used with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia.

FDA Expands Thymoglobulin Use in Renal Transplant Patients

By April 24, 2017

Thymoglobulin was originally approved for the treatment of renal transplant acute rejection in 1998. It is available as single-use 10mL vials containing 25mg of anti-thymocyte globulin as a lyophilized powder.

Imbruvica Under Review for Graft-Versus-Host-Disease

By April 05, 2017

Imbruvica is a first-in-class, oral Bruton's tyrosine kinase (BTK) inhibitor.

Researchers Grow First Human-Pig Chimeras

By January 27, 2017

Researchers have successfully grown human stem cells in pig embryos, setting in motion a path of research which could lead to human organs being grown in animals for the purpose of transplantation.

NIH May Lift Ban on Human-Animal Hybrid Stem Cell Research

By August 05, 2016

The prospect of human stem cells developing in an animal's brain also becomes a possibility, raising serious ethical dilemmas that go to the core of what it is to be human.

Envarsus XR Labeling Updated with Ethnicity-Specific Dosing

By July 07, 2016

Veloxis announced that the Food and Drug Administration (FDA) has approved updates to the Envarsus XR (tacrolimus extended-release tablets) labeling regarding pharmacokinetics (PK) and pharmacogenomics (PG) data from the ASERTAA trial.

FDA Grants Imbruvica Fourth Breakthrough Therapy Designation for cGVHD

By June 29, 2016

AbbVie announced that the Food and Drug Administration (FDA) has granted a fourth Breakthrough Therapy designation for Imbruvica (ibrutinib) and an Orphan Drug designation for the potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.

Drug Used for Organ Rejection Prophylaxis Effective in Autoimmune Hepatitis

By March 22, 2016

Mycophenolate mofetil appears safe and effective for the treatment of autoimmune hepatitis (AIH), according to the results of a study published in Alimentary Pharmacology & Therapeutics.

Envarsus XR Launched for Kidney Transplant Rejection Prophylaxis

By December 07, 2015

Veloxis announced that Envarsus XR (tacrolimus extended-release) tablets are now available for the prophylaxis of rejection in kidney transplant patients converted from immediate-release tacrolimus formulations, in combination with other immunosuppressants.

Cinryze Fast Tracked for Antibody Mediated Rejection

By October 13, 2015

The FDA has granted Fast Track designation to Cinryze (C1 esterase inhibitor [human]; Shire) as an adjunct to Donor Specific Antibodies (DSA) reduction therapy in renal transplant patients with acute Antibody Mediated Rejection (AMR).

Reduced-Dose Tacrolimus, Everolimus Cuts CMV Infection

October 05, 2015

Findings in de novo kidney recipients receiving no pharmacologic CMV prophylaxis

Once-Daily Envarsus XR Approved for Organ Rejection Prophylaxis

By July 16, 2015

Veloxis announced that the Food and Drug Administration (FDA) has approved 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.

Nearly 400 HIV-Positive Potential Organ Donors in U.S.

May 15, 2015

Although ban was lifted on such surgeries in 2013, none has taken place, researchers say

Nulojix Reduces Risk of Kidney Transplant Rejection, Mortality in Follow-Up Study

By May 07, 2015

Bristol-Myers Squibb Company announced results from the Phase 3 BENEFIT trial in kidney transplant patients receiving Nulojix (belatacept) vs. cyclosporine.

Generic Drug Found Bioequivalent to Brand for Transplant Patients

By May 04, 2015

Generic formulations of tacrolimus were found to be just as good as the brand Prograf (Astellas) version, researchers from the University of Cincinnati have found.

Outcomes Favorable for HIV+ Kidney Transplant Recipients

March 20, 2015

However, survival rates lower if organ recipient also has hepatitis C

Damaged Kidneys May Still Be Viable in Transplant

March 13, 2015

For reasons that are unclear, certain organs even performed better six months after transplant

Glassia Designated Orphan Drug for Graft-Versus-Host Disease

October 29, 2014

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Glassia (alpha1-proteinase inhibitor [human]) for the treatment of Graft-versus-host disease (GVHD).

First-in-Class Test to Predict Liver, Intestine Transplant Rejection in Children

September 12, 2014

Plexison announced that the Food and Drug Administration (FDA) has approved Pleximmune, a first-in-class blood test to predict acute cellular rejection of transplanted livers and intestines in children.

Hypernatremia Linked to Post-Liver Transplant Mortality

April 08, 2014

Pre-liver transplant (LTx) hyponatremia does not affect post-LTx survival, but hypernatremia is a significant risk factor for post-LTx mortality.

Soliris Designated Orphan Drug for Prevention of Delayed Graft Function

January 21, 2014

The FDA has granted Orphan Drug designation to Soliris (eculizumab; Alexion), a first-in-class terminal complement inhibitor for the prevention of delayed graft function (DGF) in renal transplant patients.

NDA Submitted for Envarsus in Kidney Transplant Prophylaxis

December 30, 2013

Veloxis announced the submission of a New Drug Application (NDA) to the FDA for Envarsus (tacrolimus; formerly LCP-Tacro) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.

Envarsus Designated Orphan Drug for Kidney Transplant Rejection Prophylaxis

December 26, 2013

The FDA has granted Orphan Drug designation to Envarsus (tacrolimus; Veloxis) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.

Antibodies Predict Graft Injury, Loss in Kidney Transplants

September 26, 2013

The addition of the presence of complement-binding donor-specific anti-HLA antibodies to a traditional risk model improved the prediction of graft failure.

Astagraf XL Capsules Now Available

August 22, 2013

Astellas announced the availability of Astagraf XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant.

Biomarker IDs Tx-Resistant Graft-Versus-Host Disease

August 08, 2013

Researchers found that levels of suppression of tumorigenicity 2 (ST2) were most significantly associated with outcome.

Rituximab Equally Effective for Remission of Vasculitis

August 01, 2013

Rituximab is as effective as conventional immunosuppressive therapy in maintaining remission in patients with severe ANCA-associated vasculitis.

Rabies, Fatal Encephalitis Caused by Donated Kidney

July 24, 2013

Eighteen months after receiving a kidney transplant, a recipient died from acute progressive encephalitis caused by rabies infection that had been undiagnosed in the donor.