Novo Nordisk: positive data for semaglutide
(CercleFinance.com) - Novo Nordisk reports positive results from the first part of the ongoing ESSENCE phase 3 trial, involving 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis.
Compared with placebo, its semaglutide demonstrated a statistically significant and superior improvement in hepatic fibrosis without worsening steatohepatitis, as well as resolution of steatohepatitis without worsening hepatic fibrosis.
The trial thus met its primary endpoints, and semaglutide 2.4 mg appeared to have a safe and well-tolerated profile, in line with previous trials of the drug, according to the Danish pharmaceutical company.
Novo Nordisk plans to file for regulatory approval in the US and EU in the first half of 2025. The second part of the ESSENCE trial will continue, with results expected in 2029.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
Compared with placebo, its semaglutide demonstrated a statistically significant and superior improvement in hepatic fibrosis without worsening steatohepatitis, as well as resolution of steatohepatitis without worsening hepatic fibrosis.
The trial thus met its primary endpoints, and semaglutide 2.4 mg appeared to have a safe and well-tolerated profile, in line with previous trials of the drug, according to the Danish pharmaceutical company.
Novo Nordisk plans to file for regulatory approval in the US and EU in the first half of 2025. The second part of the ESSENCE trial will continue, with results expected in 2029.
Copyright (c) 2024 CercleFinance.com. All rights reserved.