Drugs

Novo Nordisk Seeks Approval for Higher-dose Wegovy

Novo Nordisk has filed a supplemental NDA seeking approval for a higher-dose version of its weight-loss drug Wegovy (semaglutide). If approved, the company says the 7.2 mg option could deliver even greater weight loss than the blockbuster drug’s existing 2.4 mg formulation.

The drugmaker says the submission for the weekly injection is seeking review under FDA’s new Commissioner’s National Priority Voucher (CNPV) pilot — an accelerated pathway aimed at therapies addressing major national health challenges. Once the filing is formally accepted, the review is expected to take just one to two months.

The filing includes data from STEP UP, a 72-week Phase 3 trial in 1,407 adults with obesity but without diabetes, according to the company. In the study, people taking the 7.2 mg dose lost an average of 20.7% of their body weight when adhering to treatment — compared with 17.5% for those on the currently approved 2.4 mg dose and 2.4% for placebo.

One-third of participants on the higher dose achieved at least 25% weight loss, roughly double the rate seen with the 2.4 mg version, it says. When dropouts were included in the analysis, weight loss averaged 18.7% for the 7.2 mg arm versus 15.6% for Wegovy 2.4 mg.

The company says gastrointestinal side effects were more common with the higher dose, though serious adverse events occurred less often than in the 2.4 mg arm (6.8% versus 10.9%)

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