IPF patients treated with OFEV® (nintedanib) versus placebo were twice as likely to have improved or stable lung function1
Boehringer Ingelheim today announced the presentation of new analyses on the use of OFEV® (nintedanib) in treating idiopathic pulmonary fibrosis (IPF) at the 2017 American Thoracic Society (ATS) conference. Abstracts presented at the conference support the established efficacy and safety data for OFEV®, and offer further insights into its effect on lung function in IPF patients.
Pooled data from the two Phase III INPULSIS® trials showed that OFEV®-treated patients were twice as likely as those given placebo to experience an improvement or no decline in lung function, as measured by forced vital capacity (FVC), at week 52 (36.8%, OFEV® vs. 18.0%, placebo).1 A subgroup analysis of the open-label INPULSIS®-ON study demonstrated a similar annual rate of FVC decline over 96 weeks among OFEV®-treated patients, regardless of the dosage they received based on individual tolerability (150 mg twice daily, 100 mg twice daily, or both doses).2
Additionally, a pooled analysis from the TOMORROW™ and INPULSIS® trials assessed the incidence rates for major adverse cardiovascular events (MACE) among patients treated with OFEV® and placebo. Most patients included in this analysis (90%) had a high cardiovascular (CV) risk at baseline, including a history of fatty-plaque build-up in the arteries (called atherosclerosis) and/or at least one CV risk factor such as high blood pressure, diabetes or elevated blood cholesterol levels. Overall, the incidence of MACE was similar between the treatment groups both in patients with a high CV risk (3.5%, OFEV® and 3.3%, placebo) and low CV risk (4.5%, OFEV® and 5.3%, placebo) at baseline.3
“IPF is a progressive disease that requires ongoing treatment. So it is important to assess the long-term efficacy and safety of IPF treatments like OFEV® to ensure we are maintaining lung function and reducing disease progression while not exacerbating co-existing conditions,” said Imre Noth, M.D., professor of medicine and director of the Interstitial Lung Disease Program at the University of Chicago. “These new data help to further strengthen the science supporting the efficacy and safety of OFEV® for up to 96 weeks of treatment, and offer physicians additional evidence to support their treatment decisions.”
New Insights about IPF Patients
A separate analysis presented at ATS examined data from the IPF-PRO patient registry at 18 pulmonary care sites to identify the clinical characteristics of IPF patients who have advanced lung function impairment. Most clinical studies have included IPF patients with mild to moderate lung function impairment, and investigators wanted to understand how patients with more advanced disease differed. Patients with advanced IPF at baseline had greater physical impairment versus patients with mild to moderate disease, including lower six-minute walk distance (320 feet vs. 397 feet). The more advanced IPF patients also had an increased prevalence of hypoxaemia (low blood oxygen), both at rest (36.6% vs. 7.4%) and while active (62.4% vs. 20.2%), requiring more supplemental oxygen, as well as a history of pulmonary arterial hypertension, or high blood pressure in the lungs (14.0% vs. 6.4%). In addition, health-related quality of life (HRQL) scores were significantly worse in those with advanced lung function impairment.6
“Boehringer Ingelheim remains committed to research in IPF with the goal of providing further medical advances for patients suffering from this devastating disease,” said Dr. Susanne Stowasser, M.D., Global Team Lead Medical Affairs ILD, Therapeutic Area Respiratory, Boehringer Ingelheim Pharma GmbH & Co KG. “Building on our recent medical progress, we are expanding our research and development activities to other fibrosing interstitial lung diseases to address the high unmet medical need of patients affected by these conditions.”
Ongoing research is being conducted for the treatment of OFEV® in patients with IPF and other interstitial lung diseases. Nintedanib is also being investigated for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD), as well as progressive fibrosing interstitial lung disease (PF-ILD). Additionally, the first Phase IV trial following the approval of OFEV® for the treatment of IPF is completed and will add evidence to the safety and tolerability of nintedanib with add-on pirfenidone. Results from the 12 week, randomised INJOURNEY® trial will be presented at an upcoming international medical congress.
The corresponding abstracts can be found within the online programme, here: https://cms.psav.com/ats2017/confcal
~ ENDS ~
Please click on the link below for ‘Notes to Editors’ and ‘References’:
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business.
Media + PR
Dr. Kristin Jakobs
Phone: +49 6132 – 77 144553
Fax: +49 6132 – 77 6601
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Global Powerhouses Coming to CES Asia 2018: Alibaba A.I. Labs, BYTON, FAW Hongqi, Guangzhou Automobile Group, iQIYI, KIA, Leapmotor, LG Electronics, Mitsubishi Electric Automotive, Singulato, Skyworth and TCL18.3.2018 20:00 | Pressemelding
The Consumer Technology Association (CTA) today announced the newest leading global brands added to its growing exhibitor list for CES Asia 2018. Technology powerhouses including Alibaba A.I. Labs, BYTON, FAW Hongqi, Guangzhou Automobile Group, iQIYI, KIA, Leapmotor, LG Electronics, Mitsubishi Electric Automotive, Singulato, Skyworth and TCL are set to showcase their latest tech tailored toward the Asian market at CES Asia in June. “The tech showcased at CES Asia 2018 will be ground-breaking,” said John T. Kelley, senior director, international programs and show director, CES Asia. “From artificial intelligence, vehicle technology, content development and distribution to smart cities and more, the show will be packed with innovation from global brands and cutting-edge startups alike. These first time exhibitors demonstrate the incredible caliber and scope of CES Asia and attendees will be blown away this year.” BYTON, who recently unveiled its first concept all-electric vehicle at CES
Summer Business with Yourtyres.co.uk: New Shop Feature and High-Performance Tyre Models16.3.2018 14:11 | Pressemelding
Each year, summer trade means great challenges for car garages and tyre dealers. As a result and at just the right time, Yourtyres.co.uk, the online trade customer shop by Europe’s leading online tyre dealer Delticom, is introducing a new feature intended to make the daily work of the shop’s customers easier: An advice mode is available from now on at Yourtyres.co.uk. When changing from the purchasing to the sales view, the individual end customer prices are displayed instead of the actual purchase prices. In order to use this feature, users of Yourtyres.co.uk simply have to insert their individual markups for the different item groups. From the markup and the purchase price, the online shop automatically calculates the personal end customer price. The usual purchasing view is also still available. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005448/en/ An advice mode immediately helps trade customers use the full pot
Available Now: The Smartphone Made for the Way We Communicate Today, the Galaxy S9 and S9+16.3.2018 12:00 | Pressemelding
Samsung Electronics America, Inc. announced that the new, award-winning Galaxy S9 and Galaxy S9+, which have been recognized by smartphone reviewers worldwide for their best-in-class display, design and camera, are now available for purchase at U.S. wireless network providers and retail stores. The phones come in three colors: Midnight Black, Coral Blue, and the new Lilac Purple. The Galaxy S9 has a suggested retail price of $719.99, while the Galaxy S9+ is available for $839.99. Both unlocked and carrier versions of the Galaxy S9 and Galaxy S9+ are also available for purchase on Samsung.com. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005175/en/ Designed for the way we communicate today, Samsung's new Galaxy S9 and Galaxy S9+ are available in the U.S. at wireless network providers, retailers and on Samsung.com. (Photo: Business Wire) “The Galaxy S9 and S9+ are designed for the visual and social generation—the consum
CONQUEST Group Announced the Expansion of its Asset Management Business with the Appointment of Philippe Taillardat to the Role of Director16.3.2018 09:00 | Pressemelding
Philippe Taillardat brings to CONQUEST over 25 years of Asset Management and Investment Banking experience, primarily in principal investing, financial advisory, equity and debt financing across global infrastructure and sustainable energy sectors. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005030/en/ Philippe Taillardat (Photo: CONQUEST Group) Philippe was most recently Co-Head of Infrastructure Investments Europe at First State Investments, which he helped transform into one of the leading billion+ European infrastructure fund manager in core / core+ strategies. Earlier in his career, Philippe held various senior banker and investment roles at Amundi, Credit Agricole CIB, Credit Suisse, AXA and BNP Paribas. Frédéric Palanque, Managing Director of CONQUEST Group, said, "We are delighted to welcome such a recognized professional. CONQUEST is trusted for providing value-added advice in complex and highly confidential
AccelStor All-Flash Solutions Unlock Data Possibilities for AI and Cloud16.3.2018 09:00 | Pressemelding
AccelStor, an innovative all-flash array (AFA) provider for the big data era, is excited to announce its participation in the upcoming Cloud Expo Europe, taking place from March 21 to 22 at Booth C1850 in the ExCel London exhibition centre. Besides presenting latest all-flash storage solutions breaking through performance and availability barriers for artificial intelligence (AI), virtualization and private cloud, AccelStor will present a live demonstration of its new generation NeoSapphire high availability models, one of the highlights not to be missed this year. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005010/en/ AccelStor's new generation NeoSapphire High Availability all-flash array AccelStor NeoSapphire all-flash arrays are highly integrated with virtualization and private cloud platforms, supporting VMware vSphere and OpenStack Cinder. NeoSapphire’s “high availability” series features symmetric active-activ
Westinghouse Completes First Major Decommissioning Work at a Nordic Commercial Nuclear Reactor16.3.2018 08:45 | Pressemelding
Westinghouse Electric Company announced today that it has completed a major decommissioning project at the former Barsebäck nuclear power plant in Skåne, Sweden. Barsebäck Unit 2 ceased operation in 2005 and decommissioning work began in August 2016. Westinghouse’s scope of work included the underwater segmentation and packaging of the reactor vessel internals, as well as the upfront engineering studies and equipment manufacturing and qualification. “Westinghouse is proud to deliver this major decommissioning project on time and on budget,” said Yves Brachet, Westinghouse senior vice president, Global Decommissioning, Decontamination, Remediation and Waste Management. “Our global expertise in this area will help our customers in the Nordic region to safely manage a variety of end-of-life opportunities for commercial nuclear power plants.” Leadership at Barsebäck Kraft AB (BKAB) is equally satisfied with this successful initial step of the first dismantling of a commercial nuclear power