Business Wire

Efficacy and safety of OFEV® reinforced in new presentations at ATS 2018

Jaa

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 ‘References’:
http://www.boehringer-ingelheim.com/press-release/efficacy_and_safety_of_ofev_ats_2018

Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business.

Contact information

Boehringer Ingelheim
Corporate Communications
Media + PR
Alexander Kurz
Tel.: +49 (6132) 77-184531
Mobile: +49 (151) 68948378
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

HighLife Closes a €32 Million Round B Financing17.1.2019 20:25Tiedote

HighLife SAS, a medtech company focused on the development of a unique transcatheter mitral valve replacement (“TMVR”) system to treat patients suffering from mitral regurgitation, announced today it had closed a €32 million round of equity financing. Proceeds from the financing will be used to complete the development of the company’s transcatheter transseptal mitral valve implantation program, which includes regulatory approval trials in Europe to obtain the CE mark and a first clinical trial in the U.S. via an Early Feasibility Study (EFS). The Series B round was co-led by U.S. Venture Partners (“USVP”) and Andera Partners, with Sectoral Asset Management and Jose Calle Gordo, Chairman of the company, joining the round. Sofinnova Partners, which led the Series A round, continues to support the company and participated in this latest round of financing. Bryan Garnier & Co (Paris) acted as private placement agent for this financing. “I am very pleased to announce the closing of the Ser

The Brightline™ Initiative, led by Project Management Institute, to Support The Economist Davos Panel17.1.2019 18:00Tiedote

The Brightline™ Initiative, a coalition dedicated to helping executives bridge the gap between strategy design and delivery, along with Project Management Institute is hosting The Economist Events panel discussion entitled “Humans 2.0: Designing and Implementing a Future Proof Strategy.” In line with Davos’ overarching theme, “Globalization 4.0: Shaping a Global Architecture in the Age of the Fourth Industrial Revolution,” panelists will discuss how business leaders can harness the power of people to adapt and implement corporate strategies and grapple with the effects of disruptive technologies. This topic is of particular interest to PMI, the leading member of Brightline, given how this wave of disruption calls for organizations to rely on successful implementation of new strategies at unprecedented scope and speed to meet market demands. “As a coalition committed to moving from idea to strategy implementation to results, we’re delighted to partner with The Economist Events to bring

MSCI Schedules Investor Conference Call to Review Fourth Quarter and Full Year 2018 Results17.1.2019 17:00Tiedote

MSCI Inc. (NYSE:MSCI), a leading provider of indexes and portfolio construction and risk management tools and services for global investors, today announced it will release its results for the fourth quarter and full year 2018 on Thursday, January 31, 2019. MSCI's senior management will review the fourth quarter and full year 2018 results on Thursday, January 31, 2019 at 11:00 AM Eastern Time. To listen to the live event, visit the events and presentations section of MSCI's Investor Relations homepage, http://ir.msci.com/events.cfm, or dial 1-877-376-9931 conference ID: 3474708 within the United States. International callers dial 1-720-405-2251 conference ID: 3474708. The earnings release and related investor presentation used during the conference call will be made available on MSCI's Investor Relations homepage. An audio recording of the conference call will be available on our Investor Relations website, http://ir.msci.com/events.cfm, beginning approximately two hours after the conc

SailPoint Names Andrew Kahl as Chief Customer Officer17.1.2019 17:00Tiedote

SailPoint Technologies Holdings, Inc. (NYSE: SAIL), the leader in enterprise identity governance, today announced the appointment of Andrew Kahl to the role of Chief Customer Officer. In this role, Andrew will be responsible for driving the integrated customer experience for every SailPoint customer while continuing to enable and scale SailPoint’s growing post-sale partner community. He will also oversee SailPoint’s customer success, professional services and support teams, globally. “This appointment underscores our fierce commitment to our customers’ successful journey with SailPoint and is a critical step as we look to scale to thousands of customers. In his role, Andrew will help us to maintain our relentless focus on driving the best-in-class customer experience our customers have come to expect from SailPoint,” said Mark McClain, CEO and Co-Founder of SailPoint. “Customer success is in our lifeblood as an organization and I am confident that Andrew will make that his continued ch

FedEx Trade Networks Rebrands as FedEx Logistics17.1.2019 17:00Tiedote

FedEx Corp. (NYSE:FDX) announced today that FedEx Trade Networks, Inc. is being rebranded as FedEx Logistics. The new name describes the company’s ability to meet its customers’ increasingly complex and industry-specific supply chain, transportation, value-added services, and brokerage needs. FedEx Logistics provides specialty solutions that complete a simple, seamless and powerful global trade experience for FedEx customers around the world. “We’re adding tremendous value by bringing all of the specialty services we offer under the FedEx Logistics banner,” said Richard W. Smith, president & CEO of FedEx Logistics. “The global solutions we offer are dynamic and customizable, and the experience for our customers is more streamlined, more efficient and better represented as a collective competitive offering as FedEx Logistics. Our simplified customer interface and comprehensive ability to meet every logistics need will have a profound effect for FedEx customers, our team members, and on

French Lingerie Rocks the World!17.1.2019 16:00Tiedote

Following the success of its "Lingerie, Mon Amour" Show in January 2017, Promincor - Lingerie Française (Association for the Promotion of Corsetry Industries) and the DEFI (Committee of Promotion and Development for the Clothing) once again bring together leading French Lingerie brands for an exceptional Parisian Show on January 20, 2019 at 8:45 p.m. (local time), which will be live-streamed on www.lingeriefrancaise.com. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190117005060/en/ SHOW LINGERIE FRANÇAISE ROCKS (Photo: @lingeriefrancaise ) A true musical Show Fourteen prestigious French Lingerie brands (Antigel, Antinéa, Aubade, Chantelle, Empreinte, Eprise, Epure, Implicite, Passionata, Lise Charmel, Lou, Louisa Bracq, Maison Lejaby, Simone Pérèle) and 3 guest French designers (Badines Lingerie, Jolies Mômes and Henriette H) will present their latest collections to an audience of 600 people that include media, influencers

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