Drugs

Monlunabant Trial Misses End Point in Kidney Trial

Novo Nordisk says a recent Phase 2 trial of monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist, in diabetic kidney disease patients failed to meet its primary endpoint. The trial evaluated the therapy’s efficacy and safety of once-daily 10 mg and 25 mg dosing compared to placebo, particularly its effect on the “Urine Albumin-Creatinine” ratio (uACR) after 16 weeks in 254 people with diabetic kidney disease, according to the company. “The trial did not meet its primary endpoint of a statistical significant improvement on uACR with monlunabant versus placebo,” it says.

Regarding safety in the trial, Novo Nordisk says that the most common adverse events were gastrointestinal, with the vast majority being mild to moderate in severity. “Reporting of mild to moderate neuropsychiatric side effects was more frequent with monlunabant compared to placebo.”

Monlunabant (formerly INV-202), which was added to Novo Nordisk’s pipeline as part of the 2023 Inversago Pharmaceuticals acquisition, is also being evaluated for treating obesity. Results from this trial were reported 9/2024 and showed that monlunabant achieved a statistically significant weight loss compared to placebo. “After 16 weeks of treatment, people treated with a once-daily 10 mg dose of monlunabant achieved a weight loss of 7.1 kg compared to a reduction of 0.7 kg with placebo,” the company said at the time. “Limited additional weight loss was seen at higher doses of monlunabant.”

The most common adverse events in this trial were gastrointestinal, and mild to moderate neuropsychiatric side effects, primarily anxiety, irritability, and sleep disturbances, were more frequent and dose-dependent with monlunabant compared to placebo, Novo Nordisk said, adding that “no serious adverse events were reported in relation to neuropsychiatric side effects.”

Based on these results, the company said in will begin a larger Phase 2b trial this year in obesity to further investigate dosing and the safety profile of monlunabant over a longer duration in a global population.

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

Read more

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