Efficacy and safety of OFEV® reinforced in new presentations at ATS 2018
Boehringer Ingelheim today announced new presentations at the American Thoracic Society’s 2018 annual conference that reinforce the efficacy, safety and tolerability profile of OFEV® (nintedanib) in patients with idiopathic pulmonary fibrosis (IPF).
“The data presented at the conference support the established efficacy of OFEV®, while reaffirming the safety profile observed in the clinical trials and following approval,” said Christopher Corsico, M.D., Chief Medical Officer, Boehringer Ingelheim.
New IPF mortality analysis
Pooled data from the two Phase III INPULSIS® trials and the Phase II TOMORROW study compared the observed number of deaths in patients treated with nintedanib or placebo with the predicted rate of death based on GAP stage over one year.1 GAP stage is used to predict IPF prognosis and is based on gender, age and lung function (as measured by forced vital capacity [FVC] decline % predicted and DLco % predicted).1 Higher stages of GAP are associated with an increasing risk of death.1
Across the population (n=1,228), there were fewer deaths observed in each treatment group than predicted based on GAP stage at baseline (OFEV®: 42 vs. 89.9; placebo: 41 vs. 64.2).1 In the OFEV® group, the number of observed deaths was 46.7% of the number predicted based on GAP stage, while in the placebo group the number of observed deaths was 63.9% of the number predicted.1 Based on these differences, the analysis suggests that OFEV® may be associated with a 26.8% relative reduction in the risk of death compared with placebo over one year.1
“IPF is a progressive and fatal disease, and treatment with nintedanib can slow disease progression by reducing the rate of lung function decline,” said Christopher J. Ryerson, M.D., Assistant Professor at the University of British Columbia Centre for Heart Lung Innovation, Vancouver, Canada. “Although the individual trials were not powered to measure mortality, our pooled analysis suggests that nintedanib may offer a survival benefit for IPF patients.”
Lung function decline and quality of life
In a separate analysis of data from the INPULSIS® trials, a greater decline in lung function was associated with worsening patient-reported health-related quality of life (HRQoL) measuring respiratory function, shortness of breath, cough and sputum assessment and other quality of life measures.2 Pooled data from patients treated with nintedanib or placebo showed that patients with a decline in FVC >10% predicted, regardless of treatment, experienced declines across different HRQoL measures.
“The symptoms of IPF can have a serious impact on a patient’s quality of life, resulting in a loss of independence and involvement in daily activities,” Michael Kreuter, M.D., Professor at the Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, University of Heidelberg, and a Member of the German Center for Lung Research, Germany. “Our analysis demonstrated an association between the extent of lung function decline and quality of life. Stabilizing lung function, therefore, may allow patients to retain some of their daily level of functioning, which might improve quality of life.”
Pooled safety data from six trials
Data from the largest set of OFEV®-treated patients with IPF analyzed to-date further confirmed its safety and tolerability profile.3 The analysis included patients from six clinical trials (n=1,126), including TOMORROW, the two INPULSIS® trials, and their open-label extension studies.3
The average exposure to OFEV® was 27.7 months with a maximum exposure of 93.1 months, for a total of nearly 2,600 patient-years.3 The rate of adverse events leading to permanent dose reduction (from 150 mg twice daily to 100 mg twice daily) or discontinuation from the studies were 12.8 and 23.8 events per 100 patient exposure-years, respectively.3 Diarrhea remained the most common AE, and led to dose reduction or discontinuation in 17.2% and 8.8% of patients, respectively.3 In the pooled data, the rate of diarrhea was lower than observed in the Phase III INPULSIS® trials.3
The corresponding abstracts can be found within the ATS online program, here: http://www.abstractsonline.com/pp8/#!/4499
Please click on the link below for ‘Notes to Editors’ and
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business.
Media + PR
Tel.: +49 (6132) 77-184531
Mobile: +49 (151) 68948378
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
Tory Burch Names Pierre-Yves Roussel Chief Executive Officer11.12.2018 21:26 | Pressemelding
Tory Burch, LLC, today announced it has named Pierre-Yves Roussel Chief Executive Officer, starting early 2019. A longtime LVMH executive, Mr. Roussel will be based out of Tory Burch’s New York headquarters; he will join and report to the Company’s board of directors. In partnership with Ms. Burch, he will lead and implement the company’s global strategy with a focus on operations. “There are very few leaders in the industry who have both a commercial track record and a deep admiration for the creative process. I respect what he has built at LVMH and value the way he thinks about business, luxury and the fashion industry as a whole. He also shares my belief in the importance of a culture-led company. We have a strong management team in place and Pierre-Yves is a natural fit as we continue to focus on long-term growth and global expansion,” said Tory Burch, who is currently Chief Executive Officer and will assume the role Executive Chairman and Chief Creative Officer. “I’m very excited
United Nations Climate Action Award Goes to Germany for the First Time11.12.2018 19:00 | Pressemelding
Within the context of the United Nations Framework Convention on Climate Change, two ProVeg projects were awarded the Momentum for Change Climate Action Award 2018 in the category Planetary Health. One of these is the health promotion project Aktion Pflanzen-Power, jointly initiated with BKK ProVita. ProVeg and its partner received the award for their work in schools. It marks the first time that this award has gone to Germany. The award ceremony took place yesterday in the Polish city of Katowice as part of the 24th UN Climate Change Conference. ProVeg and BKK ProVita promote children’s health and climate action Aktion Pflanzen-Power aims to improve the availability and quality of vegan and vegetarian dishes in schools. Together with BKK ProVita, ProVeg has so far reached 24,800 students at 41 schools throughout Germany on the subject of wholesome, plant-based nutrition as part of the health promotion project. Healthy nutrition with Aktion Pflanzen-Power Andreas Schöfbeck, member of t
Thales and Gemalto are granted regulatory clearance by the European Commission11.12.2018 17:01 | Pressemelding
Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto announce today that they have been granted merger control Regulatory Clearance by the European Commission, following Thales’s commitment to divest its general purpose hardware security modules (GP HSM) business globally1 to a suitable purchaser. This clearance is effective immediately. Together with the merger control clearances obtained in China, Israel, South Africa and Turkey, and clearances relating to f
Starr Insurance Companies Expands Aviation Insurance Operations to Brazil11.12.2018 15:43 | Pressemelding
Starr Insurance Companies today announced that Starr International Brasil Seguradora S.A. (“Starr Brazil”) has been granted a local license to offer aviation insurance. “We are thrilled to be adding aviation capability in an important, growing economy like Brazil,” stated Steve Blakey, president and chief executive officer for Starr Insurance Holdings, Inc. “As a worldwide leader in aviation insurance solutions, we are constantly seeking new opportunities and markets to meet the growing needs of the aviation and aerospace industry around the globe.” Fernanda Strachino, aviation specialist underwriter, has joined Starr Brazil to head the new aviation division. Fernanda brings more than 16 years’ of experience in the aviation and insurance market. Starr Brazil will offer a variety of aviation coverages, including: Aircraft Hull & Liability; Spare Parts; Third-Party Legal Liability; Corporate Non-Owned Aircraft Liability; General Liability; RETA Insurance (Mandatory Liability), Hangarkeep
Andersen Global Continues Growth in United Kingdom With Claritas Tax Limited11.12.2018 14:30 | Pressemelding
Today, Andersen Global expanded its reach in the United Kingdom with the addition of Claritas Tax Limited, a tax advisory and compliance services firm based in Birmingham, the second largest city in the country. Claritas is the fourth firm collaborating with Andersen Global in the UK. “Adding a sought-after firm like Claritas is not only a logical extension for Andersen Global, but it broadens our offering in the UK. Their practice focuses on corporation tax, R&D tax reliefs, mergers and acquisitions, private equity and venture capital in addition to serving individuals,” said Mark Vorsatz, Andersen Global Chairman and Andersen Tax LLC CEO. “Iain Wright and his team enhance our already robust core competences in the UK, a critical market for our clients, and we look forward to working with Claritas on a number of upcoming corporate opportunities.” Founded in 2012, Claritas Tax Limited is an advisory led business that provides a full range of tax advisory and compliance services to entr
Seoul Semiconductor Wins Patent Litigation against Everlight in Germany and Is Awarded Statutory Litigation Costs11.12.2018 14:00 | Pressemelding
Seoul Semiconductor Co., Ltd. (KOSDAQ:046890) (“Seoul”), a leading global innovator of LED products and technology, announced that it won a patent litigation against Everlight Electronics Co., Ltd. (“Everlight”) in Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181211005233/en/ Seoul Semiconductor's Headquarters in Korea (Photo: Business Wire) The patent involved in this litigation relates to an LED package structure for thermal dissipation. Everlight purchased this patent from a U.S. company in 2017, and subsequently brought a patent lawsuit against Seoul in the Manheim Court of Germany. In December 2018, however, the Manheim Court ruled in favor of Seoul and ordered that Everlight, as the losing party, should bear the statutory costs of the court proceeding. In the United Kingdom, Seoul had already won a patent litigation against Everlight earlier this year. At that time, the UK Patent Court also ordered that Ever