Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for Investigational Treatment for NASH
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210602005582/en/
Contact information
Media Contacts
Boehringer Ingelheim
Dr. Birgit Leimer
Product Communications Manager
Boehringer Ingelheim Corporate Center GmbH
Media + PR
E-Mail: press@boehringer-ingelheim.com
Zealand Pharma Investor Relations
Claudia Styslinger
Argot Partners
E-Mail: investors@zealandpharma.com
Zealand Pharma Media Relations
David Rosen
Argot Partners
E-Mail: media@zealandpharma.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
HCLTech Reports FY24 Revenue of $13.3 Billion, up 5.4% YoY26.4.2024 23:06:00 EEST | Press release
HCLTech, a leading global technology company, today reported financial results for the fourth quarter and the full year ended March 31, 2024. The company reported full year revenue of $13.3 billion, up 5.4% YoY. Digital Services revenue grew by 5.3% (CC) and now contributes to 37.3% of IT Services revenue. HCLSoftware’s Annual Recurring Revenue came in at $1.02 billion. During FY24, the company won 73 large deals – 36 in Services and 37 in Software - that translated into TCV (new deal wins) of $9.76 billion, up 10% YoY. For the quarter, revenue came in at $3.43 billion, up 6% YoY. HCLTech won 21 large deals – 13 in Services and eight in Software, with a TCV of $2.29 billion during the quarter. In terms of geographies, Americas was the fastest growing region with 6.8% YoY (CC) growth followed by Europe, which grew by 5.5% YoY (CC). Industry vertical growth was led by Financial Services and Telecommunications, Media, Publishing & Entertainment. While Financial Services grew at 12.1% YoY
Kinaxis Positioned Highest on Ability to Execute in the Gartner® Magic Quadrant™ for Supply Chain Planning Solutions26.4.2024 19:03:00 EEST | Press release
Kinaxis® Inc. (TSX:KXS), a global leader in end-to-end supply chain orchestration, today announced it has been named a Leader in the 2024 Gartner® Magic Quadrant™ for Supply Chain Planning Solutions. Of the 20 vendors evaluated, Gartner positioned Kinaxis highest on Ability to Execute, marking the company’s 10th consecutive Leaders Quadrant within the report, a complimentary copy of which can be downloaded here. Kinaxis attributes its position to its patented concurrency approach and a proven track record of delivering innovative solutions against the foundation of its leading vision through the use of advanced technology such as AI, ML, and an intuitive user experience. Bolstered by a rich ecosystem of third-party implementation partners, Kinaxis continues to demonstrate that regardless of a customer’s industry, size, or maturity level, the company can be counted on to seamlessly orchestrate supply chain networks end-to-end from strategic planning to last-mile delivery. The recognitio
Vertex Announces European Commission Approval for KALYDECO® to Treat Infants With Cystic Fibrosis Ages 1 Month and Older26.4.2024 18:43:00 EEST | Press release
Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that the European Commission has granted approval for the label expansion of KALYDECO® (ivacaftor) for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. “Today’s approval is an important milestone for the cystic fibrosis community. Treating CF early in life can potentially slow the progression of the disease, which is why it is so important to start treatment from a very young age,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer, Vertex. As a result of existing access agreements in Austria, Czech Republic, Denmark, Ireland, Norway, Sweden, and The Netherlands, eligible patients will have access to the expanded indication of KALYDECO® (ivacaftor)
Suzano 2023 annual report on Form 20-F26.4.2024 18:22:00 EEST | Press release
Suzano S.A. (B3: SUZB3 | NYSE: SUZ) informs that its 2023 Annual Report on Form 20-F was filed today with the U.S. Securities and Exchange Commission. Holders of the Company’s equity securities can receive hard copies of the Annual Report, including its audited financial statements, without charge by request directed to: ri@suzano.com.br. This document is also available on Suzano’s website (http://ir.suzano.com.br/). For further information, please contact our Investor Relations Department: Phone: (+55 11) 3503-9330 E-mail: ri@suzano.com.br View source version on businesswire.com: https://www.businesswire.com/news/home/20240426289818/en/ Contact information Hawthorn Advisors suzano@hawthornadvisors.com
Takeda Receives Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer26.4.2024 15:30:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (mCRC). The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for mCRC throughout the European Union (EU), Norway, Liechtenstein and Iceland. If approved, fruquintinib will be the first and only selective inhibitor of all three VEGF receptors approved in the EU for previously treated mCRC.1,2 “People living with metastatic colorectal cancer in the European Union currently have limited treatment options, which can lead to poor outcomes. With this positive opinion for fruquintinib, we are one step closer to potentially offering patients a new
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