Drugs

Hold Removed on Rezolute Hypoglycemia Drug

FDA has removed a partial clinical hold against Rezolute’s RZ358 (ersodetug), a potential treatment for hypoglycemia caused by congenital hyperinsulinism. (HI) Ersodetug is currently being evaluated in the sunRIZE global Phase 3 study in participants with congenital HI, the company says, and the hold removal will permit it to begin “start-up activities” to include U.S. participants in the study. It expects U.S. enrollment to begin in early 2025, which will enable topline data from the study to be released in the second half of of the year.

Rezolute says that in removing the hold, FDA concluded that the “liver toxicity observed in Sprague Dawley rats is likely strain-specific and not otherwise relevant to humans.” It adds that “Coming on the heels of our recent announcement of FDA clearance of a separate Phase 3 study in tumor-associated HI, we are in the unique and fortunate position to be advancing ersodetug in two Phase 3 rare disease programs in the U.S. and globally.”

Ersodetug is described as a monoclonal antibody that binds to a unique allosteric site on insulin receptors to counteract the effects of insulin receptor over-activation. This improves hypoglycemia in HI patients, the company says, adding that ersodetug acts downstream from the pancreas and has the potential to be effective at treating hypoglycemia due to any form of HI.

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