Drugs

FDA Approves First Treatment for Debilitating Itch in Liver Disease

FDA has approved GSK’s Lynavoy (linerixibat), the first U.S.-authorized therapy specifically for cholestatic pruritus in patients with primary biliary cholangitis, according to a company release. The action provides a long-awaited treatment option for a condition that affects up to 89% of people with PBC — an autoimmune liver disease in which disrupted bile flow leads to a severe, persistent internal itch that can significantly impair quality of life.

Linerixibat belongs to a class of drugs known as ileal bile acid transporter inhibitors. By blocking the reabsorption of bile acids in the gut, the therapy reduces circulating compounds believed to drive the intense itching associated with the disease, the company says.

FDA’s decision was based on results from the Phase 3 GLISTEN trial, a randomized, placebo-controlled study that demonstrated statistically significant improvements in both itch severity and sleep disruption, GSK says. Patients receiving linerixibat experienced measurable relief as early as two weeks, with benefits sustained over a 24-week period. The trial met both its primary endpoint — reduction in itch severity—and key secondary endpoints, including improved sleep.

GSK says the the most commonly reported side effects were gastrointestinal, including diarrhea and abdominal pain. These were generally mild to moderate, though a small percentage of patients discontinued treatment due to these effects.

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