Business Wire

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

Share

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

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

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

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Midea Group releases its first-ever ESG brand story with an unexpected VIP visit highlighting its commitment to sustainability.29.3.2024 02:39:00 CET | Press release

Midea Group: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328526418/en/ Background: Midea Group, a leading global technology group, recently released its 2023 Environmental, Social, and Governance (ESG) Report with ambitious sustainable development goals set for 2030. They include achieving over 500 megawatts of photovoltaic power generation, reducing greenhouse gas emission intensity (scopes 1 and 2) by 0.040, secure Energy Management System Certification for 50 factories, and achieve 100% carbon footprint accounting for major categories of smart home appliances. This is aligned with the Sustainable Development Report Standards of the Global Report Standards of the Global Reporting Initiative (GRI). The new report and campaign focuses on four dimensions: Protect the Blue Planet, Build a Harmonious Community, Practice 'Bring Great Innovations to Life', and Jointly Create the Prosperous Ecology. The campaign: Midea’s ESG

DC Secretary Announces Annual Determinations Committees Outcome28.3.2024 21:14:00 CET | Press release

DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 27, 2024. Voting Dealers (for all regions): Voting Non-Dealers (for all regions): Bank of America N.A. Citadel LLC Barclays Bank plc Elliott Management Corporation BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Voting Dealer for the Americas, EMEA, AEJ, and Japan Determination Committees: Mizuho Securities Co., Ltd. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. View source version on businesswire.com: https://www.businesswire.com/news/home/20240328441002/en/Contact information Press Inquiries: Orlando Figueroa orlando.figueroa@citadelspv.com

LambdaTest Launches The Phoenix Project, an Employee Resource Group for Women28.3.2024 16:00:00 CET | Press release

LambdaTest, a leading cloud-based unified testing platform, announced the launch of The Phoenix Project, an Employee Resource Group (ERG) dedicated to supporting and promoting the success of its female employees. “LambdaTest is committed to fostering a diverse, inclusive, and equitable workplace where all employees feel valued and empowered to reach their full potential,” said Chandini Chopra, VP of People and Culture at LambdaTest. “The Phoenix Project is a critical step towards achieving this goal by providing a platform for professional development, networking, and mentorship, especially for our women employees.” The Phoenix Project Aims To: Offer professional development workshops, networking opportunities, and dedicated time off for women to participate in ERG initiatives. Provide mentorship programs connecting senior female employees with mentees. Promote leadership development among women within the company. Create a sense of community for women in the workplace. Leadership and

The reopening of the Yokohama Museum of Art adds another innovative and distinctive venue for events in Yokohama28.3.2024 16:00:00 CET | Press release

After extensive renovations, the iconic Yokohama Museum of Art has reopened its doors to visitors from all over the world. The museum’s reopening paves the way to new and closer collaboration with international events in Yokohama. This extraordinary venue is the ideal setting for a one-of-a-kind gathering, in part, supported by the Yokohama Convention & Visitors Bureau (hereinafter YCVB). The Yokohama Museum of Art Founded in 1989, the Yokohama Museum of Art collects over 14,000 works of art that reflect the many facets of life in Yokohama—past, present, and future. The reopening of the museum coincides with the Yokohama Triennale, an international exhibition featuring contemporary artists whose decentralized exhibits turn the entire metropolis into an art museum. The 8th Yokohama Triennale is being held from March 15 to June 9, 2024, with the Yokohama Museum of Art being a pivotal venue for the exhibition. With the museum firmly back on the map as Yokohama’s leading artistic venue, YC

Eight new sustainability-themed experiences—exclusive to Yokohama—for convention participants28.3.2024 16:00:00 CET | Press release

In a survey conducted by Yokohama Convention & Visitors Bureau (hereinafter YCVB), many convention attendees expressed particular interest in Yokohama’s culture, sightseeing spots, and local cuisine. In response, YCVB has developed eight new Yokohama Tours for event attendees to enjoy during their free time in Yokohama, keeping in line with our ethos of sustainability. Noge Area Bar-Hopping Tour, complete with guide Known affectionately by locals as Yokohama’s kitchen, Noge is a bustling nightlife spot that is home to over 600 izakaya (Japanese-style pubs). A knowledgeable local guide will lead participants to all the hidden gems in Noge, where they can indulge in distinctive, delicious pub-style food and drink. With easy on-foot accessibility, participants can rest assured this fun night out won’t impact their carbon footprint. Soto Zen Tour of Sojiji, head temple of the Soto Zen school As a prominent Zen sect in Japan, Soto Zen provides one of the best Zen wellness experiences. Durin

HiddenA line styled icon from Orion Icon Library.Eye