Drugs

Wegovoy OK’d for Metabolic Steatohepatitis

FDA has granted Novo Nordisk accelerated approval for a new Wegovy (semaglutide) indication for treating metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in conjunction with a reduced calorie diet and increased physical activity, according to the company.

The approval is based on data from the phase 3 ESSENCE trial investigating the effects of once-weekly Wegovy 2.4 mg injection on liver histology in adults with MASH and moderate to advanced liver fibrosis at Week 72. The trial met its primary endpoint, showing 63% of people treated with Wegovy “achieved resolution of steatohepatitis and no worsening of liver fibrosis compared to 34% on placebo,” Novo Nordisk says. Data also showed that 37% of people treated with Wegovy achieved improvement in liver fibrosis and no worsening of steatohepatitis compared to 22% on placebo. There is an ongoing study to confirm the clinical benefit of Wegovy in adults with MASH, it says.

MASH is a serious form of fatty liver disease, which can be potentially life-threatening if not properly managed, Novo Nordisk says, adding that about one out of three people who are overweight or obese are affected by the condition.

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