Big News for Boehringer: FDA Grants Breakthrough Therapy Status for Survodutide

Zealand Pharma, a biotechnology firm dedicated to creating innovative peptide-based therapies, has announced that Boehringer Ingelheim received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for survodutide (BI 456906). This dual glucagon/GLP-1 receptor agonist is aimed at treating adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced fibrosis (stages 2 or 3).

The Breakthrough Therapy designation is designed to accelerate the development and review of drugs targeting serious or life-threatening conditions, particularly those that demonstrate significant potential to outperform existing therapies. Additionally, Boehringer Ingelheim has launched two Phase III clinical trials for survodutide, focusing on adults with MASH and associated fibrosis.

The LIVERAGE study will assess the efficacy of survodutide in improving metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis over a 52-week treatment period. It aims to determine if the medication can lower the risk of developing end-stage liver disease outcomes in around 1,800 adults with moderate to advanced liver fibrosis (stages 2 or 3) over approximately seven years.

Similarly, the LIVERAGE-Cirrhosis trial will focus on whether survodutide can mitigate the risk of end-stage liver disease in approximately 1,590 adults diagnosed with MASH and compensated cirrhosis (fibrosis stage 4), a serious condition characterized by significant liver scarring, over a treatment duration of about four and a half years.

David Kendall, M.D., Chief Medical Officer of Zealand Pharma, “Representing one of the most serious and fastest-growing obesity-related co-morbidities with limited treatment options available today, we are both pleased and excited to see Boehringer Ingelheim advance survodutide into two Phase III trials in MASH in both F2/F3 patients (moderate to advanced fibrosis) as well as F4 patients (cirrhosis). 

He further stated, “The U.S. FDA Breakthrough Therapy Designation follows the impressive and groundbreaking Phase II data with survodutide in MASH and fibrosis presented earlier this year which provided evidence of clear differentiation that position survodutide as a potentially leading incretin-based therapy for obesity and MASH in the future.”