Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for Investigational Treatment for NASH

• FDA’s Fast Track Designation for the GLP-1/glucagon dual agonist underscores the urgent need for new treatment options to fulfill the unmet medical needs of people affected by NASH.
• Boehringer Ingelheim’s focus on the development of next generation NASH treatments builds on its strong track record of bringing new therapies to people with cardiometabolic diseases.

(BUSINESS WIRE)-- Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078) today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the GLP-1/glucagon dual agonist BI 456906 for adults with non-alcoholic steatohepatitis (NASH). The Fast Track Designation facilitates the development and expedites the review of new therapies to treat serious conditions and fill an unmet medical need. BI 456906 is currently being evaluated in a Phase II study in adults with NASH and liver fibrosis (F2/F3) with and without diabetes.

“The FDA Fast Track Designation for our dual agonist is an important step forward in addressing the high unmet medical need among the up to 444 million adults estimated to be living with NASH,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Together with our partner Zealand Pharma, we look forward to working closely with the FDA as we explore the potential of the GLP-1/glucagon agonist to improve outcomes for adults with NASH.”

“Boehringer Ingelheim and Zealand Pharma are committed to delivering innovative solutions that address public health challenges of cardiometabolic diseases, including NASH,” said Adam Steensberg, Executive Vice President and Chief Medical Officer at Zealand Pharma. “By combining Boehringer Ingelheim’s expertise in drug development in the cardio-metabolic area with our strength in the discovery of innovative peptide-based medicines, we have the potential to bring forward a novel therapy option in an area with limited available treatments.”

The GLP-1/glucagon compound derived from the natural gut hormone oxyntomodulin activates both the GLP-1 and glucagon receptors that are critical to controlling metabolic functions. The dual agonist BI 456906 has the potential to be a new, once-weekly treatment that may offer therapeutically relevant benefits compared to currently available treatments. It is also being investigated as a potential treatment option for adults living with diabetes and for adults living with obesity. It is part of Boehringer Ingelheim’s research and development portfolio in the cardiometabolic disease areas.

Please click on the following link for ‘Notes to Editors’:
http://www.boehringer-ingelheim.com/press-release/fast-track-designation-nash

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