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
Loxam Announces a Conditional Agreement to Acquire UK Platforms20.7.2018 14:51 | Pressemelding
Loxam Group (“Loxam”) announces that its wholly-owned subsidiary Nationwide Platforms Limited (“Nationwide”) has entered into a conditional agreement with HSS Hire Group plc (“HSS”) with respect to the acquisition of UK Platforms Limited (“UKP”). UKP specializes in renting powered access equipment from its 12 branches located throughout the United Kingdom. The company has approximately 130 employees and operates a fleet of 3,000 units. UKP is controlled by HSS since 2013. As part of this transaction, Nationwide has entered into a commercial agreement with HSS to provide powered access equipment to complement HSS’ existing fleet. The closing of the transaction is subject to the approval by HSS’ shareholders and the confirmation that it will not be referred to the Competition and Mergers Authority. The transaction is expected to close before year end 2018. Don Kenny, CEO of Loxam’s Powered Access Division states: “I am delighted with the acquisition of UKP which will further reinforce NW
Schlumberger Announces Second-Quarter 2018 Results20.7.2018 11:00 | Pressemelding
Schlumberger Limited (NYSE: SLB) today reported results for the second quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2018 Mar. 31, 2018 Jun. 30, 2017 Sequential Year-on-year Revenue $8,303 $7,829 $7,462 6% 11% Pretax operating income $1,094 $974 $950 12% 15% Pretax operating margin 13.2% 12.4% 12.7% 75 bps 45 bps Net income - GAAP basis $430 $525 $(74) -18% n/m Net income, excluding charges & credits* $594 $525 $488 13% 22% Diluted EPS - GAAP basis $0.31 $0.38 $(0.05) -18% n/m Diluted EPS, excluding charges & credits* $0.43 $0.38 $0.35 13% 23% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Schlumberger Chairman and CEO Paal Kibsgaard commented, “The second quarter was both busy and exciting for Schlumberger as we completed a number of major milestones in preparation for the broad-based global activity upturn that is now emerging. We delivered solid top-line gro
H.I.G. Capital Announces the Sale of KidsFoundation19.7.2018 19:50 | Pressemelding
H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €21 billion of equity capital under management, announced today that one of its affiliates has entered a definitive agreement to sell the KidsFoundation Group (“KidsFoundation”), the Dutch market leader in childcare services, to Onex Corporation (“Onex”)(TSX:ONEX). Terms were not disclosed. Headquartered in Almere, the Netherlands, KidsFoundation provides high-quality childcare to nearly 30,000 children between the ages of six weeks and 12 years. H.I.G. created KidsFoundation in 2014 through the acquisition of assets from the estate of Estro Group. During H.I.G.’s ownership, the company has developed strongly with significant capital invested by H.I.G. to create a high-quality childcare offering. H.I.G. worked with KidsFoundation management to optimise the footprint of the company by exiting loss-making locations, introduce new IT systems to drive operational improvement and develop an internal M&
SIG Combibloc Group Holdings S.à r.l.: 2018 Second Quarter Results19.7.2018 16:01 | Pressemelding
We are pleased to announce our quarterly conference call to discuss the results of SIG Combibloc Group Holdings S.à r.l. for the second quarter ended June 30, 2018. Date: Monday, July 23, 2018 Time: 15.00 CEST / 14.00 BST / 9.00 EDT The call information will be distributed on our secure site. If you would like access to our call, please contact email@example.com . Regards, SIG Combibloc Group Holdings S.à r.l. View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005634/en/ Contact information SIG Combibloc Group Holdings S.à r.l. Jennifer Gough firstname.lastname@example.org
NEORIS Announces Creation of Innovation Labs Worldwide to Create a Smarter Future19.7.2018 15:32 | Pressemelding
NEORIS, a global digital consulting services company, announced today it is consolidating the most innovative solutions it has developed in different geographies and allocating unprecedented resources to deploy a network of Innovation Labs worldwide. The main objective is to lay the foundation for the continuous development of disruptive solutions for its four core industries: Manufacturing, Financial Services, Healthcare and Telecommunications. Due to its disruptive nature, NEORIS decided that its first Innovation Lab should be housed in the Monterrey Digital Hub, which today is the first-of-its-kind as it is a space where entrepreneurs, companies, universities and investors converge to foster an ecosystem for Digital Transformation. The lab inaugurated in Monterrey, Mexico is the first of a series of Innovation Labs that will open in the different countries that NEORIS operates, and is a space where customers can experience emerging technologies through real-life scenarios. One such
CORRECTING and REPLACING Albar Capital Deploys FlexNOW19.7.2018 15:29 | Pressemelding
Subhead of release should read: Out-of-the-Box Multi-Asset Execution Management System (instead of Easy-to-Install Multi-Asset Execution Management System). The corrected release reads: ALBAR CAPITAL DEPLOYS FLEXNOW Out-of-the-Box Multi-Asset Execution Management System FlexTrade (@FlexTrade) today announced that Albar Capital Ltd., a new hedge fund led by Javier Velazquez (formerly of Millennium Capital Partners LLP), is now trading equities and futures using FlexNOW, FlexTrade’s new execution management system. “The FlexNOW team was instrumental in solving several of our problems,” said Jason Ruder, Trader at Albar Capital. “Not only are they helping us with our compliance requirements, they are also responsive to requests that improve my workflow.” According to Rhyd Lewis, FlexNOW Product Manager, FlexNOW’s quick onboarding and easy installation process was critical for Albar Capital’s launch on 2 July. “We had no problem integrating FlexNOW with Albar’s portfolio and risk managemen