Business Wire

European Commission approves third nintedanib indication in pulmonary fibrosis1

Share

Boehringer Ingelheim today announced that the European Commission (EC) has approved an additional indication for nintedanib in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF).1 The approval comes after the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in May 2020.3 The U.S. Food and Drug Administration (FDA), Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) recently approved nintedanib as the first treatment for the same patient population.4,5,6

Interstitial lung diseases encompass a large group of more than 200 disorders that may involve the threat of pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function.7 People living with fibrosing ILD can develop a progressive phenotype, leading to lung function decline, deterioration in quality of life and early mortality similar to those with IPF, the most frequent form of idiopathic interstitial pneumonias.8 The course of the disease and the symptoms are similar in progressive forms of chronic fibrosing ILDs regardless of the underlying ILD diagnosis, and as many as 18% to 32% of patients with non-IPF ILDs are estimated to be at risk for developing a progressive fibrosing disease behavior.9,10

The approval is based on the results of INBUILD®, which was a randomized, double-blind, placebo-controlled, parallel-group phase III trial, which evaluated the efficacy, safety, and tolerability of nintedanib in patients with chronic fibrosing ILDs with a progressive phenotype.2 The primary endpoint was the annual rate of decline in forced vital capacity (FVC) in mL assessed over a 52-week period. Patients on placebo lost 188mL lung volume over a year, while patients on nintedanib lost 81mL. This was measured as adjusted annual rate of decline over 52 weeks and meant that nintedanib slowed the lung function decline by 57% versus placebo.2 The treatment effect of nintedanib in slowing FVC decline compared with placebo seen in INBUILD® was consistent for all patients, regardless of the fibrotic pattern on high-resolution computed tomography (HRCT) and it was also consistent with the results in nintedanib trials studying patients with IPF and SSc-ILD.2,11,12,13

In the trial, nintedanib was associated with numerical reductions in the risk of acute exacerbation or death versus placebo.2 Treatment benefit may also be accompanied by reduced worsening of patient-reported outcomes such as dyspnea and cough.14 In addition, the safety profile observed in INBUILD® was consistent to what has been seen in patients with IPF and SSc-ILD treated with nintedanib previously.2

“Making your voice heard when living with a rare life-threatening condition can be very hard and also frightening, especially if no treatment option is available,” said Liam Galvin, Secretary of the European Idiopathic Pulmonary Fibrosis and Related Disorder Federation (EU-IPFF). “The European Commission’s decision is great news for people who are at risk of developing pulmonary fibrosis due to a progressive ILD. Pulmonary fibrosis causes irreversible decline in lung function and this new indication brings much hope to those affected and their loved ones.”

“We are very pleased with the European Commission’s decision to approve nintedanib as the first treatment in the EU for a group of chronic fibrosing ILDs that are progressing,” added Peter Fang, Senior Vice President and Head of Therapeutic Area Inflammation at Boehringer Ingelheim. “Living with fibrotic diseases greatly impacts the lives of the affected. Various underlying diseases can lead to the development of pulmonary fibrosis and until now, no treatment option was available. Bringing new hope to those patients constitutes a therapeutic breakthrough.”

~ENDS~

Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/ecapprovalnintedanibildpf

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Boehringer Ingelheim
Corporate Communications
Media + PR
Alexander Kurz
55216 Ingelheim/Germany
Tel.: +49 (6132) 77-184531
Mobile: +49 (151) 68948378
Email: press@boehringer-ingelheim.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Kyowa Kirin Provides Update on Application for Marketing Authorisation of Istradefylline in Europe for the Treatment of ‘OFF’ Episodes in People Living with Parkinson’s23.7.2021 17:05:00 EEST | Press release

Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, “Kyowa Kirin”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an add-on treatment to levodopa (L-Dopa) based regimens in adults living with Parkinson’s, experiencing end-of-dose motor fluctuations. Kyowa Kirin International remain committed to istradefylline and people living with Parkinson’s and are currently reviewing the options available, which may include re-examination. “We are disappointed by the CHMP opinion. However, we remain confident in the benefit-risk profile of istradefylline and are committed to making a difference to the lives of people living with Parkinson’s, an area which has had few innovative therapies for decades,” said Abdul Mullick, President of Kyowa Kirin International. “There are currently few new treatment options available to manage end-of-dose motor fluctuations in Parkinson

ForumPay Teams Up with Bambora to Conquer the Crypto-to-Fiat Payments Market23.7.2021 16:16:00 EEST | Press release

ForumPay, an international cryptocurrency-to-fiat payment service provider, has established a partnership with the global payments provider Bambora, a Worldline brand, to bring seamless crypto payment solutions to merchants and online shoppers. The partnership will cater to a large global audience and offer expanded payment options for both shoppers and merchants. ForumPay continues its march to dominate the growing crypto payments ecosystem for merchants around the world. “ForumPay provides merchants with a seamless, secure and instant processing solution to accept payments from the more than 54 million active crypto wallet users around the world. By providing a payments service for processing crypto into fiat that functions as naturally as card payments, ForumPay enables merchants with a familiar feeling payments alternative that also gives them a competitive advantage by tapping into the fastest growing consumer base on the planet.” says Joshua Tate, CEO of ForumPay. “We are very ex

Wipro Recognized as 2021 Microsoft Modernizing Applications Partner of the Year23.7.2021 15:54:00 EEST | Press release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has won the 2021 Microsoft Partner of the Year Award in the Modernizing Applications category. In addition, Wipro was also named as a category finalist in the 2021 AI Partner of the Year category, solidifying its reputation as an innovator in multiple sectors. This recognition highlights Wipro’s deep expertise and ability to go above and beyond for its customers, powered by an established partnership with Microsoft. Even when working with complex customer environments, spanning across hundreds of servers with different applications of different versions, Wipro was able to help customers meet their business needs and leverage the power of public cloud in an efficient way. “Global enterprises have embraced modernization at an unprecedented scale and pace, and the demands of the past year show no sign of easing. We are honor

Merck Announces Appointment of Head of China & International for Healthcare23.7.2021 14:45:00 EEST | Press release

Merck, a leading science and technology company, today announced that Hong Chow will join its Healthcare business sector as Head of China & International on October 1. In this role at Merck, Chow will lead China, Japan as well the regions Europe, Latin America, Asia-Pacific and Middle East, Africa and Russia, the franchise of Cardiovascular Metabolism & Endocrinology (CM&E), and the Global Business Innovation team. Chow will report to Peter Guenter, Member of the Executive Board of Merck and CEO Healthcare. She will serve as a member of the Healthcare Executive Committee, and be based in Shanghai, China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210723005186/en/ Merck Announces Appointment of Head of China & International for Healthcare (Photo: Business Wire) “Hong’s international experience and strong track record of bringing innovative medicines to patients in need across both developed and emerging markets, most nota

H.I.G. WhiteHorse Refinances Grupo Recoletas23.7.2021 14:03:00 EEST | Press release

H.I.G. WhiteHorse, a credit affiliate of global investment firm H.I.G. Capital ("H.I.G.") is pleased to announce that it has arranged a refinancing package for Grupo Hospitalario Recoletas (“Recoletas”), which includes a significant growth capital component. Recoletas is a family-owned Spanish private hospital operator headquartered in Valladolid, Spain, with a leading position in the Castilla y Leon Spanish inland region. It operates 8 hospitals with c. 540 beds and 13 medical centres across 7 regions. H.I.G. WhiteHorse has committed €110 million in unitranche loans to refinance the borrower's existing indebtedness and provide additional capital to finance growth, supporting the Company’s expansion. Recoletas is currently developing ambitious projects to expand its healthcare services provided through hospitals and medical centers, as well as diagnostic imaging centers and radiotherapy units. Amando J. Rodríguez, President and CEO of Grupo Hospitalario Recoletas, said: “We are very ha

Schlumberger Announces Second-Quarter 2021 Results23.7.2021 13:50:00 EEST | Press release

Schlumberger Limited (NYSE: SLB) today reported results for the second-quarter 2021. Second-Quarter Results (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2021 Mar. 31, 2021 Jun. 30, 2020 Sequential Year-on-year Revenue* $5,634 $5,223 $5,356 8% 5% Income (loss) before taxes - GAAP basis $542 $386 $(3,627) 40% n/m Net income (loss) - GAAP basis $431 $299 $(3,434) 44% n/m Diluted EPS (loss per share) - GAAP basis $0.30 $0.21 $(2.47) 43% n/m Adjusted EBITDA** $1,198 $1,049 $838 14% 43% Adjusted EBITDA margin** 21.3% 20.1% 15.6% 118 bps 561 bps Pretax segment operating income** $807 $664 $396 22% 104% Pretax segment operating margin** 14.3% 12.7% 7.4% 162 bps 694 bps Net income, excluding charges & credits** $431 $299 $69 44% 525% Diluted EPS, excluding charges & credits** $0.30 $0.21 $0.05 43% 500% Revenue by Geography International $4,511 $4,211 $4,224 7% 7% North America* 1,083 972 1,097 11% -1% Other 40 40 35 n/m n/m $5,634 $5,223 $5,356 8% 5% *Schlum

Wyss Center Partners With Artiria Medical to Accelerate a Novel Therapy for Cerebral Vasospasm23.7.2021 12:59:00 EEST | Press release

The Wyss Center and Artiria Medical today announced a new partnership to accelerate the translation of a novel technology that has the potential to reduce deaths and improve quality of life for stroke patients. Artiria Medical, an early-stage medical device company focused on disruptive neurovascular products, has been developing the technology and is now joining forces with the Wyss Center, a non-profit organization dedicated to bringing state-of-the-art therapies to the patient. The team has received support from the Swiss Innovation Agency, Innosuisse, to test and validate the efficacy of the therapy preclinically, in preparation for human clinical studies. Stroke is the third leading cause of disability worldwide with more than 80 million people living with long-term impairments as a result. Some strokes result in bleeding in the brain. Such hemorrhagic strokes can lead to severe cerebral vasospasm - an uncontrolled contraction of brain arteries - in the days that follow, depriving

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom