Drugs

FDA Extends Review of Rhythm’s Setmelanotide sNDA

FDA has extended by three months its review of Rhythm Pharmaceuticals’ supplemental NDA for Imcivree (setmelanotide) and its use in treating acquired hypothalamic obesity. The revised user fee review action target date is 3/20/2026.

The review extension is related to an agency request for additional sensitivity analyses of clinical efficacy data from Rhythm’s Phase 3 trial, according to the company. The new analyses have been classified as a “major amendment,” which automatically triggers an extension of the FDA’s review clock to allow for full evaluation. Rhythm said the amendment does not involve any new information about safety or manufacturing.

“Setmelanotide has demonstrated a compelling product profile, and we have every confidence that these additional sensitivity analyses confirm the strength of the data,” the company said in a release.

If approved, Imcivree would become the first FDA-approved therapy for patients with acquired hypothalamic obesity, a rare and severe condition characterized by rapid weight gain following damage to the hypothalamus, often due to surgery, trauma, or tumors. The drug was originally approved in 2020 for treating obesity and hyperphagia in patients with genetically confirmed Bardet-Biedl syndrome or certain forms of monogenic obesity due to POMC, PCSK1, or LEPR deficiencies.

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