Drugs

Veopoz OK’d and Eylea Issues Fixed: Regeneron

FDA has approved a Regeneron Pharmaceuticals BLA for Veopoz (pozelimab-bbfg) for treating adult and pediatric patients one year of age and older with Chaple disease, also known as CD55-deficient protein-losing enteropathy. Veopoz is described as a monoclonal antibody designed to target complement factor C5, a protein involved in complement system activation.

The company says the approval also confirms the resolution of earlier-reported pre-approval inspection issues (see story) related to the company’s BLA for a higher dose of Eylea (aflibercept) 8 mg to treat patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. FDA action on the aflibercept 8 mg BLA is expected in the next few weeks, it adds. Earlier this month, the agency told Regeneron and contract vial filler Catalent that certain manufacturing data and other information were required to allow approval of the submission.

“Chaple is an ultra-rare and life-threatening hereditary immune disease driven by an overactivation of the complement system,” Regeneron says. Those living with Chaple are unable to regulate complement activity due to mutations in their CD55 gene. “Without proper CD55 regulation, the complement system may attack normal cells, causing damage to blood and lymph vessels along the upper digestive tract and leading to the loss of circulating proteins,” it 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