Drugs

FDA Approves BMS Orencia for Graft Versus Host Disease

FDA has approved a new indication for Bristol-Myers Squibb’s Orencia (abatacept) to be used in combination with certain immunosuppressants to prevent acute graft versus host disease. An agency announcement says the disease occurs when donor bone marrow or stem cells attack the graft recipient.

Orencia may be used in adults and pediatric patients age 2 and older undergoing hematopoietic stem cell transplantation, the notice says. It is the first FDA approval for acute graft versus host disease prevention and incorporated real-world evidence as one component of the determination of clinical effectiveness.

FDA says the safety and efficacy of Orencia in combination with immunosuppressant therapy in patients age 6 and older who underwent stem cell transplantation from a matched or mismatched unrelated donor were evaluated in two studies. Additional evidence of effectiveness was provided by GVHD-2, a registry-based clinical study conducted using real-world data from the Center for International Blood and Marrow Transplant Research in patients who underwent stem cell transplantation from a mismatched unrelated donor.

Orencia received FDA Breakthrough, Orphan Drug, and Priority Review designations for this indication. The development of the drug was partially supported by the agency’s Orphan Products Grants Program.

The notice says Orencia was originally approved by FDA in 2005 to treat adult rheumatoid arthritis. It also is approved to treat polyarticular juvenile idiopathic arthritis and adult psoriatic arthritis.

The review of Orencia for this indication was conducted under Project Orbis, an initiative in the FDA Oncology Center of Excellence that provides a framework for the concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with Health Canada, Swissmedic, and the Israeli Ministry of Health.

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