BOEHRINGER-INGELHEIM
2.6.2021 14:02:09 CEST | Business Wire | Press release
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20210602005582/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Mirum Pharmaceuticals and Incyte Announce U.S. FDA Approval of Atebrioz™ (zilurgisertib) for Adult and Pediatric Patients with Fibrodysplasia Ossificans Progressiva26.9.2026 01:00:00 CEST | Press release
-Once-daily oral ALK2 inhibitor approved to reduce the volume of total new heterotopic ossification in patients aged 12 years and older with FOP-Atebrioz expected to be available in the United States in October through Mirum Access Plus (MAP), with eligible patients paying as little as $0 per month-PROGRESS pediatric development program continues to evaluate zilurgisertib in children aged 2 to <12 years Mirum Pharmaceuticals, Inc. (Nasdaq:MIRM) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Atebrioz™ (zilurgisertib) tablets to reduce the volume of total new heterotopic ossification (HO) in adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP). The recommended dose of Atebrioz is 100 mg administered orally, once daily. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260925436454/en/ “Today marks an important milestone for pe
Digital Reef Signs Offtake Agreement with Oreasoc Agriculture to Mitigate the Environmental Footprint of Data Centre Growth Through Rainforest Protection, Appointing Xange.com as Digital MRV Partner25.9.2026 21:19:00 CEST | Press release
The offtake agreement connects Digital Reef’s 3.3 GW data centre pipeline with environmental assets from more than 30 million hectares of Amazon rainforest across South America, where Oreasoc Agriculture works directly on the ground alongside local communities to develop sustainable economies and safeguard their territories. Xange.com’s digital MRV technology monitors both the data centres and the rainforest. At Climate Week NYC, Digital Reef and Oreasoc Agriculture Inc. sign an offtake agreement connecting Digital Reef’s 3.3 GW data centre pipeline with environmental assets exceeding 30 million hectares of South American Amazon rainforest, mitigating the environmental footprint of data centre growth through rainforest protection and restoration where Oreasoc works alongside local communities to protect biodiversity, develop sustainable economies and safeguard their territories. Xange.com are appointed as digital MRV technology partner to monitor the data centres and rainforest where D
NetApp Announces Intent to Acquire PEAK:AIO to Advance Scalable AI Infrastructure Architecture25.9.2026 15:00:00 CEST | Press release
Planned acquisition strengthens NetApp's position in the rapidly growing AI infrastructure market by bringing differentiated metadata innovation and parallel file architecture designed for AI NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced its intent to acquire PEAK:AIO, a pioneer in next-generation metadata architecture and high-performance parallel file systems. The planned acquisition is expected to accelerate NetApp's AI infrastructure roadmap by augmenting metadata services and parallel namespace innovation designed to help AI clouds scale shared storage alongside growing GPU clusters. As AI becomes embedded in every enterprise workload, organizations are confronting a new challenge: traditional storage architectures were not designed for the unprecedented scale, concurrency, and performance requirements of AI factories, AI clouds, and next-generation data-intensive applications. NetApp is building an architecture that disaggregates metadata fr
MultiBank Group Secures Two Awards at Forex Expo Dubai 202625.9.2026 14:57:00 CEST | Press release
The Group was recognised for the strength of its global institutional ecosystem and its contribution to financial markets innovation and community impact MultiBank Group, one of the world’s largest financial derivatives institutions, received two awards during its participation at Forex Expo Dubai 2026, held on 22 and 23 September at Dubai World Trade Centre. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260925539591/en/ MultiBank Group was named “Best Global Institutional Financial Ecosystem of the Year” and received the award for “Excellence in Global Financial Markets Innovation and Community Impact.” The Group was named “Best Global Institutional Financial Ecosystem of the Year” and received the award for “Excellence in Global Financial Markets Innovation and Community Impact.” The first award recognised the strength and breadth of MultiBank Group’s global institutional offering, which brings together trading, liquidity
Croma-Pharma Introduces saypha® volume prime Lidocaine25.9.2026 14:04:00 CEST | Press release
New cross-linked hyaluronic acid filler replaces saypha® volume Lidocaine, offering physicians a more versatile solution for both midface volumization and nasolabial folds Croma-Pharma introduces saypha® volume prime Lidocaine, a cross-linked hyaluronic acid dermal filler that replaces saypha® volume Lidocaine within the company's saypha® portfolio. The new product offers physicians a more versatile solution with expanded indications for both midface volumization and nasolabial folds, backed by strong clinical data. 1,2 saypha® volume prime Lidocaine demonstrated non-inferiority to comparatora in a randomized, subject- and evaluator-blinded, controlled, non-inferiority multicenter, parallel group comparison study with almost 500 patients.2 In the clinical evaluation, a high patient satisfaction highlights improved midface fullness, smoothness and contour, consistent with a rheologic profile designed to provide volumization in the mobile midface.b,2 With saypha® volume prime Lidocaine,
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom