Drugs

Livmarli, Bylvay Get Liver Injury/Bleeding Updates

FDA has issued safety-related labeling updates for two bile acid transport inhibitors — Mirum Pharmaceuticals’ Livmarli (maralixibat) and Ipsen Biopharmaceuticals’ Bylvay (odevixibat) — to emphasize increased risks of liver injury and bleeding associated with their use. The changes are based on new data from expanded clinical trials and postmarketing experience, an agency notice says. Both drugs are approved to treat cholestatic pruritus, a severe and persistent itching in patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC), which are genetic liver disorders that often begin in early childhood.

When first approved, labeling for maralixibat and odevixibat noted mild liver enzyme elevations seen in clinical trials. However, newer data have shown a risk for more severe hepatotoxicity, FDA says. As a result, both drugs are now contraindicated in patients with prior or current hepatic decompensation, a condition that includes complications such as variceal bleeding, ascites, or hepatic encephalopathy.

FDA says patients with ALGS and PFIC are already at risk for fat-soluble vitamin deficiencies, and the use of the two therapies can worsen the condition. “With increased patient exposure through clinical trials and postmarket use, there have been more reports of bleeding,” the agency says. “The updated labeling for maralixibat and odevixibat expands on the discussion of bleeding as an adverse reaction in the Warnings and Precautions and in the Adverse Reactions sections.

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