German pharmaceutical company Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its drug candidate survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist, for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate or advanced fibrosis (stages 2 or 3). This designation follows the initiation of two Phase III clinical trials for survodutide in the treatment of MASH and fibrosis.
Survodutide, originally developed by Zealand Pharma AS and licensed to Boehringer Ingelheim with exclusive global development and commercialization rights, has shown significant improvements in MASH without worsening fibrosis in clinical trials. The drug is expected to provide a new treatment option for patients with MASH and could redefine the treatment landscape for this condition, which is associated with significant morbidity and limited therapeutic options . – Flcube.com
