Business Wire

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

Del

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

Om 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.

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

First Data Polska Deploys Inside Secure’s Mobile Payment Technology To Securely and Easily Connect to Mastercard and Visa22.10.2018 15:36Pressemelding

Regulatory News: Inside Secure (Paris:INSD) (Euronext Paris: INSD), at the heart of security solutions for mobile and connected devices, today announced that First Data Polska S.A., a division of the global leader in commerce-enabling technology, selected Inside Secure technology to enable secure and flexible connections to Mastercard and Visa. First Data Polska S.A. chose Inside Secure’s Mobile Payment Client to easily integrate their solution with the Visa Token Service (VTS) and Mastercard Digital Enablement Service (MDES) – today’s major tokenization services that convert sensitive data into unique tokens that allow mobile payments to be processed. “Security and reliability are continual requirements for our services,” said Jolanta Rycerz, Member of Management Board at First Data Polska S.A. “We see Inside Secure as a valuable technology provider that enables us to easily migrate to the latest mobile payment technology and security standards. Thanks to Inside Secure, our customers,

PMI Launches Search for Next President and CEO22.10.2018 14:00Pressemelding

Project Management Institute (PMI), the world’s leading professional membership organization for project managers, announced today that it has retained Heidrick & Struggles to help the organization find its next President and Chief Executive Officer (CEO). The dynamic leader shall oversee the implementation of a new strategic plan and guide the organization toward a future designed to help thousands of project professionals around the world accelerate their careers and make ideas a reality. Heidrick & Struggles is a premier provider of executive search, leadership assessment and development, organization and team effectiveness, and culture shaping services globally. PMI will conduct a comprehensive global review of both internal and external candidates for this key position. The selected candidate will embody PMI’s core values and possess the skillsets necessary to advance the organization’s key goals. PMI’s next President and CEO will help it execute a bold new multi-year initiative d

E2open to Acquire INTTRA, Adding the World’s Leading Ocean Shipping Network and Software Provider, Creating an Integrated Global Supply Chain and Logistics Operating Network22.10.2018 13:43Pressemelding

E2open, the one place in the cloud to run your supply chain, today announced the acquisition of INTTRA, the leading ocean shipping network, software and information provider. The combination of INTTRA’s ocean carrier and shipper network with E2open’s industry leading business network will create a unified global logistics and supply chain network. E2open and INTTRA will join efforts to strengthen the connections and streamline the information flow between manufacturers, suppliers, shipping service providers, ocean carriers and all the participants in global trade. E2open is the largest cloud-based provider of networked supply chain solutions, featuring a complete portfolio of applications that enable the world’s most complex supply chains to better plan, collaborate, and execute their end-to-end operations. More than 70,000 partner companies and 200,000 users, many of the biggest brands and manufacturers across a range of industries, use the E2open network and platform to orchestrate t

Patient-Data Platform Raremark Raises £3m to Enable Precision Medicine in Rare Disease22.10.2018 12:00Pressemelding

Raremark, the leading patient-data platform in rare disease, has raised £3m in funding from investors, led by AlbionVC and Ananda Ventures, with participation from Oltre Venture and from existing major investor the Cass Entrepreneurship Fund. The funding will be used to develop Raremark’s patient-engagement and data-analysis technology, helping biopharmaceutical companies to identify, engage and learn from patients, accelerating the development of new treatments. Raremark’s platform is the foundation for building research networks of rare disease patients and their families. Raremark provides biopharmaceutical companies with access to anonymized and aggregated patient data, helping to reduce the time and cost of clinical development. The Raremark platform engages and retains patients, leveraging machine-learning technologies in novel ways. The approach is designed to raise health literacy and informed participation in medical research, to improve the quality of existing therapies and t

Celltrion Healthcare Hosts Forum with Patient Advocacy Groups to Provide Information on the Use of Biosimilars in Oncology22.10.2018 11:50Pressemelding

To coincide with the ESMO 2018 Congress in Munich, Germany, Celltrion Healthcare invited perspective from experts including a physician and pharmacist to provide information to patient advocacy groups on the history of biosimilars, how they are tested and approved, their cost saving benefit and the wealth of clinical evidence already available on their use in order to improve understanding of biosimilars. The introduction of biosimilars in the treatment of cancer has the potential to reduce pressure on healthcare budgets and increase access to other innovative treatments or more potent regimens. This is achieved by offering more cost-effective alternatives to the reference medicinal products and by increasing competition in the market. Breast cancer is the most common cancer in women worldwide and accounts for a quarter of all cancer diagnoses in women.1 For the benefits of biosimilar use to be realised in oncology, and in the treatment of breast cancer, barriers to their uptake need t

Sony Corporation Selects ANAQUA for IP Management22.10.2018 11:00Pressemelding

Anaqua, Inc., the leading provider of innovation and intellectual property (IP) management solutions, today announced that multinational technology company Sony Corporation has entered into a multi-year agreement to use the ANAQUA software to manage its patent and trademark portfolios. Sony is one of the world’s largest technology and entertainment companies, with products spanning consumer electronics, smart phones, game and network services, financial services, and professional products. “We are excited to welcome one of the world’s largest companies and IP leaders to Anaqua’s growing client community,” said Bob Romeo, CEO of Anaqua. “Sony’s decision to strategically partner with Anaqua for their IP Management system reinforces our continued investment in the APAC market.” ABOUT ANAQUA The most innovative companies in the world innovate with Anaqua. Its simplified software platform combines insight from big data analytics with critical tools, best practice workflows and advanced serv