Business Wire

FDA grants Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease

Jaa

Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD). The FDA’s Fast Track designation facilitates the development of new therapies that treat serious conditions and fulfill an unmet medical need in an effort to get treatments to those in need sooner.

This designation is based on Boehringer Ingelheim’s Investigational New Drug application (IND) of nintedanib for the treatment of SSc-ILD and the anticipated efficacy and safety data from SENSCIS™ (Safety and Efficacy of Nintedanib in Systemic SClerosIS), a double-blind, randomized, placebo-controlled global Phase III trial. This pivotal study is fully enrolled, including more than 520 patients from 32 countries.

“This Fast Track designation is an encouraging step in our ongoing research and commitment to advancing care of those with systemic sclerosis with interstitial lung disease,” said Christopher Corsico, M.D., Chief Medical Officer, Boehringer Ingelheim. “It is critical that we address the significant unmet medical need of those living with this disease and we are looking forward to working with the FDA to advance the development of this potential therapy.”

Annelise Rønnow, president of FESCA (The Federation of European Scleroderma Associations), added: “There are only very few drugs assessed in clinical trials for scleroderma with lung involvement – a devastating reality for people living with the disease. We appreciate that the FDA recognised the importance of the development in this field.”

Systemic sclerosis, also known as scleroderma, is a rare disease characterized by the thickening and scarring of connective tissue of multiple organs in the body, typically affecting women between ages 25 and 55. Most people with the disease will develop some degree of lung scarring, or interstitial lung disease (ILD), which is the leading cause of death among people with systemic sclerosis.

Nintedanib, which is marketed as OFEV®, is approved for a rare lung disease called idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by annual rate of decline in lung function. Because SSc-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, Boehringer Ingelheim is evaluating the impact of nintedanib on SSc-ILD.

~ Ends ~

Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/fdafasttrackdesignation

For more information, please visit:  www.boehringer-ingelheim.com

Further Media Channels

www.facebook.com/boehringeringelheim

www.twitter.com/Boehringer

Contact information

Boehringer Ingelheim
Dr. Kristin Jakobs
Corporate Communications
Media + PR
Phone: +49 (6132) 77 14 45 53
Fax: +49 (6132) 77-6601
Email: press@boehringer-ingelheim.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Papa John’s Appoints Marvin Boakye as First Chief People Officer23.1.2019 18:02Tiedote

Papa John’s International, Inc., (NASDAQ: PZZA) one of the world’s largest pizza delivery companies, announced today the appointment of Marvin Boakye as its first Chief People Officer. He will serve as a member of the Papa John’s Executive Leadership Team and report to President and CEO Steve Ritchie. Boakye has more than 20 years of human resources experience, as well as expertise in change management and culture transformation. He has held human resources leadership roles for organizations across the United States, Canada and Latin America. Boakye joins Papa John’s after serving as vice president of human resources at petroleum company Andeavor in San Antonio, Texas, which was recently acquired by Marathon Petroleum. Prior to Andeavor, he was chief human resources officer for MTS Allstream, a telecommunications company now part of Bell Canada, and held senior human resources positions at Goodyear, Pulte Group and The Home Depot. “Boakye’s expertise will help us to continue to push Pa

Global Technology Association ISACA Launching Future-focused Initiatives in Its 50th Anniversary Year23.1.2019 17:22Tiedote

Now more than 450,000 engaged professionals and 140,000 members strong, global information technology association ISACA was founded by seven individuals as the EDP Auditing Association in California at the dawn of the information systems era—1969. Serving audit, governance, risk and cybersecurity professionals and their enterprises, today ISACA has a presence in 188 countries. Headquartered near Chicago, Illinois, USA, ISACA also established an entity in Beijing, China, last year, and acquired the CMMI Institute in 2016. In 2019—its 50th anniversary year—ISACA has adopted the theme, “Honoring Our Past. Innovating Our Future.” The organization has multiple initiatives planned to mark this milestone, including: Transforming IT Audit initiative—In February 2019, ISACA will launch a Transforming IT Audit microsite with resources to help IT auditors successfully navigate the future of the profession, including emerging areas like AI and blockchain, and featuring results from ISACA’s new glo

Wipro Ranked Third Fastest Growing Global IT Services Brand in 201923.1.2019 17:18Tiedote

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, has been ranked the third fastest growing global IT services brand in 2019 in a study conducted by Brand Finance, the world’s leading brand valuation firm. Wipro is also among the top 10 most valuable brands in the global IT services sector. According to Brand Finance’s IT Services annual report for 2019, which features 15 leading brands in the segment, Wipro has a total brand value of USD 4.002 billion, up 25% on year, emerging as one of the strongest brands in the category with an AA+ Brand rating. Brand Finance, in their official press release noted that Wipro’s significant investments in digital transformation capabilities, niche acquisitions, and a recent brand refresh, have propelled it to the third fastest growing brand in the segment. The report analyses the brand value and brand strength of the 5000 largest brands across 38 sectors in t

Velodyne Lidar and YellowScan Lead Drone Surveying Market for Highway Capacity Expansion23.1.2019 16:00Tiedote

Velodyne Lidar, Inc. today announced that the YellowScan Surveyor from YellowScan has utilized Velodyne’s groundbreaking sensor technology to generate precise mapping data for an infrastructure construction project on one of Central Europe’s busiest roadways. YellowScan Surveyor, an unmanned aerial vehicle (UAV) surveying system, improves upon previous time-intensive manual surveying processes by providing a more efficient method for collecting landscape data with increased precision and detail. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190123005054/en/ Ventus-Tech using YellowScan Surveyor, which includes Velodyne Lidar’s Puck™, to generate precise mapping data. (Photo: Business Wire) The project was conducted by Ventus-Tech using YellowScan Surveyor to collect data along a 47-kilometer segment of the M1 highway (E60, E65, E75) in northwestern Hungary. The data, gathered by 88 UAV flights over one month, enabled engine

PMI Among Elite Group of Companies to Score A for Climate Change23.1.2019 15:00Tiedote

Philip Morris International Inc. (PMI) (NYSE: PM) has been highlighted as a global leader on corporate climate action by environmental impact nonprofit CDP, achieving a place on the CDP Climate Change A List for the fifth consecutive year. As the only tobacco company to have scored an A, PMI has been recognized for cutting emissions, mitigating climate risks and developing the low-carbon economy, based on its 2018 disclosure to CDP. “Climate change is one of major concerns for humanity, and companies can make a difference. Just like we are leading our industry’s transformation toward a smoke-free future, we are focused on bettering every part of our business and supply chain to become a leader in sustainable business practices,” said André Calantzopoulos, Chief Executive Officer, PMI. The company’s efforts to reduce the environmental footprint of its operations focus on sustainable design in new facilities, energy efficiency in manufacturing processes, greener purchasing of electricity

STEMCELL Technologies Launches mTeSR™ Plus, a Next-Generation Culture System for Human ES and iPS Cell Maintenance23.1.2019 14:00Tiedote

STEMCELL Technologies has released mTeSR™ Plus, an enhanced version of mTeSR™1, the most widely published feeder-free human pluripotent stem cell (hPSC) maintenance medium. The new medium has undergone successful beta testing with several members of the Stem Cell COREdinates group and has completed rigorous in-house validation testing. Designed to promote a more consistent cell culture environment through sustained medium pH and stabilized components including FGF2, mTeSR™ Plus prevents the rapid onset of acidosis. This helps avoid conditions that have been associated with DNA damage, genomic instability, and growth arrest in hPSCs. The stabilization enhancements allow for greater hPSC expansion rates, enhanced culture morphology, and truly versatile feeding schedules including the option to skip weekends. “With the launch of mTeSR™ Plus, STEMCELL is positioned to set new industry standards in the pluripotent stem cell research field,” says Dr. Allen Eaves, President and CEO of STEMCEL

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme