Drugs

Expanded Use of Prograf Relied on RWE

FDA has approved a new use for Astellas Pharma’s Prograf (tacrolimus), based on real-world evidence (an observational study), for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric patients receiving lung transplantation. The drug was originally approved for preventing organ rejection in patients receiving liver transplants, and subsequently for preventing organ rejection for kidney and heart transplants as well. An FDA release says Prograf is the only approved immunosuppressant drug product for lung transplant patients.

“This approval reflects how a well-designed, non-interventional study relying on fit-for-purpose real-world data (RWD), when compared with a suitable control, can be considered adequate and well-controlled under FDA regulations,” the agency says. Specifically, it used RWD from the U.S. Scientific Registry of Transplant Recipients. Data were collected on all lung transplants in the U.S. and were supplemented by information from the Social Security Administration’s Death Master File, a “trusted repository of mortality data,” FDA says.. “A dramatic improvement in outcomes was observed among lung transplant patients receiving Prograf as part of their immunosuppression medications compared to the well-documented natural history of a transplanted drug with no or minimal immunosuppressive therapy.”

Additionally, confirmatory evidence from randomized controlled trials of Prograf used in other solid organ transplant settings and clinical evidence from research publications supported the expanded use, according to the agency.

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