Semalutide was approved by FDA for the first time since 2021 to be applicable to adult patients with an initial body mass index (BMI) of 30 kg/m2 or higher (obesity) or 27 kg/m2 or higher (overweight) and at least accompanied by type 2 diabetes or dyslipidemia, as an auxiliary treatment to reduce calorie diet and increase physical activity. And the treatment of a weight related complication, such as hypertension.
Semaglutide was approved by the FDA on August 15, 2025, for the treatment of non cirrhotic metabolic dysfunction associated steatohepatitis (MASH) with moderate to severe liver fibrosis (in accordance with the F2 to F3 fibrosis staging), previously known as non-alcoholic steatohepatitis (NASH).
The indications for MASH are granted accelerated approval based on disease improvement and fibrosis improvement. The continued approval of this indication may depend on the validation and description of clinical benefits in confirmatory trials.
<Reprinted from Medicine Robot>
