Devices

C-Path Seeks Kidney Transplant Biomarker Qualification

FDA-backed Critical Path Institute’s (C-Path) Transplant Therapeutics Consortium (TTC) has submitted the iBox Scoring System for CDER’s Biomarker Qualification Program. TTC provided information supporting the qualification of the iBox Scoring System as a reasonably likely surrogate endpoint for clinical trials evaluating immunosuppressive therapies for use in kidney transplant recipients. C-Path says it has received a positive response from FDA to its Letter of Intent (LOI) detailing the decision to accept the iBox into the program and inviting the group to submit a qualification plan, a stage two submission that details how the consortium will demonstrate the clinical and analytical validity of the composite biomarker panel.

In the LOI, TTC says it provided information to support the qualification of the iBox Scoring System for its proposed context of use as a reasonably likely surrogate endpoint in clinical trials intended to evaluate immunosuppressive therapies for individuals living with a kidney transplant. Qualification as a surrogate endpoint would allow drug sponsors to pursue accelerated approval, removing a significant barrier to kidney transplant drug development, the group says.

Long-term graft failure rates after kidney transplantation remain high, despite improved short-term outcomes, with 10-year all-cause graft failure approaching 50%, C-Path says. The iBox Scoring System, developed by the Paris Transplant Group, is the first tool of its kind to seek regulatory qualification for use in kidney transplant clinical trials. “To date, no biomarkers have been qualified for use as a surrogate or reasonably likely surrogate endpoint in any therapeutic area,” it adds.

iBox is a risk prediction tool that combines measurements of kidney function, immunological status, and pathological assessment of kidney biopsy histology to predict the risk of graft-loss up to seven years after the time of risk assessment. It has been extensively validated for use in the treatment of individual patients in the clinical care setting, C-Path says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome