semaglutide oral once-daily (NN9932) / Novo Nordisk - LARVOL DELTA

FDA Awards Second Batch of National Priority Vouchers (FDA) - "Upon submission of a complete application, national priority voucher holders will receive a decision within months, a drastic reduction of the typical review timeline....The following products were selected following external applications and internal nominations from FDA review divisions:...(i) Casgevy for sickle cell disease; (ii) Orforglipron for obesity and related health conditions; (iii) Wegovy for obesity and related health conditions."

FDA event • Obesity • Sickle Cell Disease

Novo Nordisk submits EU application for new weight loss pill (MedWatch) - "Novo Nordisk has submitted an application to the EMA for the company’s Wegovy in a 25 mg tablet form."

EMA filing • Obesity

Novo Nordisk has also submitted a supplemental application in the US for a once-daily oral formulation of semaglutide under the trade name Wegovy for the treatment of obesity (PRNewswire) - "A decision is expected later this year."

FDA filing • Obesity

Novo Nordisk presents four new analyses on oral semaglutide 25 mg (Wegovy in a pill) at ObesityWeek 2025, including demonstrated reductions in cardiovascular risk factors (PRNewswire) - "Results showed that in the overall trial population, a higher percentage of participants with pre-diabetes at baseline achieved normal blood glucose (sugar) at week 64 in the semaglutide group versus placebo (71.1% versus 33.3%). Participants treated with oral semaglutide 25 mg were more likely to achieve ≥15% body weight reduction, compared with those who received placebo. Within the semaglutide group, more people who achieved ≥15% body weight reduction saw larger improvements than those with <15% weight reduction in systolic (−10.1 mmHg versus −4.1 mmHg, mean change from baseline) and diastolic (−4.3 mmHg versus −1.1 mmHg, mean change from baseline) blood pressure readings."

P3 data • Obesity

Novo Nordisk expects to launch an oral obesity drug in the U.S. next year, once the Food and Drug Administration approves it. (Fierce Health Care)

Launch US • Obesity

Novo Nordisk to present new data in oral semaglutide 25 mg (Wegovy in a pill) and obesity pipeline at ObesityWeek 2025 (PRNewswire) - "New data from OASIS 4 on oral semaglutide 25 mg to reveal insights on cardiometabolic health among adults with obesity or overweight; Additional trial insights into impact on ability to do everyday activities and women's health among adults with obesity or overweight will also be shared, New CagriSema data from REDEFINE to be presented, highlighting innovative pipeline"

Clinical data • Obesity

Novo Nordisk to launch oral Wegovy weight loss pill on telehealth sites - report (SeekingAlpha) - "Novo Nordisk...will launch an oral version of its blockbuster weight loss drug Wegovy (semaglutide) -- assuming it wins US FDA approval -- on telehealth sites, such as WeightWatchers (WW)....If approved, the pill would launch in early 2026. Novo filed an application with the FDA in April."

Launch US • Obesity

Novo Nordisk’s oral semaglutide 25 mg (Wegovy in a pill) delivered 16.6% weight loss in people with obesity in a newly published study (GlobeNewswire) - "When looking at the effect regardless of whether the participants took the medicine exactly as they should, people taking oral semaglutide 25 mg still achieved an average weight loss of 13.6% versus 2.2% with the placebo. Close to a third (29.7%) had a weight loss of 20% or more versus 3.3% for placebo."

P3 data • Obesity