FDA grants Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD). The FDA’s Fast Track designation facilitates the development of new therapies that treat serious conditions and fulfill an unmet medical need in an effort to get treatments to those in need sooner.
This designation is based on Boehringer Ingelheim’s Investigational New Drug application (IND) of nintedanib for the treatment of SSc-ILD and the anticipated efficacy and safety data from SENSCIS™ (Safety and Efficacy of Nintedanib in Systemic SClerosIS), a double-blind, randomized, placebo-controlled global Phase III trial. This pivotal study is fully enrolled, including more than 520 patients from 32 countries.
“This Fast Track designation is an encouraging step in our ongoing research and commitment to advancing care of those with systemic sclerosis with interstitial lung disease,” said Christopher Corsico, M.D., Chief Medical Officer, Boehringer Ingelheim. “It is critical that we address the significant unmet medical need of those living with this disease and we are looking forward to working with the FDA to advance the development of this potential therapy.”
Annelise Rønnow, president of FESCA (The Federation of European Scleroderma Associations), added: “There are only very few drugs assessed in clinical trials for scleroderma with lung involvement – a devastating reality for people living with the disease. We appreciate that the FDA recognised the importance of the development in this field.”
Systemic sclerosis, also known as scleroderma, is a rare disease characterized by the thickening and scarring of connective tissue of multiple organs in the body, typically affecting women between ages 25 and 55. Most people with the disease will develop some degree of lung scarring, or interstitial lung disease (ILD), which is the leading cause of death among people with systemic sclerosis.
Nintedanib, which is marketed as OFEV®, is approved for a rare lung disease called idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by annual rate of decline in lung function. Because SSc-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, Boehringer Ingelheim is evaluating the impact of nintedanib on SSc-ILD.
~ Ends ~
Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/fdafasttrackdesignation
For more information, please visit: www.boehringer-ingelheim.com
Further Media Channels
Dr. Kristin Jakobs
Media + PR
Phone: +49 (6132) 77 14 45 53
Fax: +49 (6132) 77-6601
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 jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Experience the Tour de France live with Mytyres.co.uk and Continental25.4.2018 19:05 | Tiedote
Steeped in tradition, the world’s most famous cycling race is soon to kick off for the 105th time. Customers of Mytyres.co.uk now have the unique opportunity to travel to Paris and watch as the teams cross the finishing line in one of the world’s most popular sporting events. In cooperation with premium manufacturer Continental, the online shop is giving away 15 places on a trip to the final stage of the Tour de France on the Champs-Élysées on 29th July 2018. Travel, accommodation, and transport is included for all participants. Participation is very easy. Simply buy at least 2 Continental summer tyres via Mytyres.co.uk before 6th May 2018, complete the registration form on the order confirmation page, and cross your fingers! The Continental tyre range available to customers on Mytyres.co.uk includes all current summer models. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180425006242/en/ Experience the Tour de France live
Al Kasir Group Launches Diamond Trading on Blockchain25.4.2018 19:01 | Tiedote
Members of the Private Office of H.H. Sheikh Ahmad Bin Obaid Al Maktoum L.L.C., AL KASIR JEWELLERY TRADING L.L.C. and AL KASIR PORTAL L.L.C. announced the launch of Diamond Trading on Blockchain with three Diamond-backed Blockchain-Assets. These Assets are stored in highly secure Digital Blockchain Wallets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180425006234/en/ Dr. Amit Lakhanpal, Founder and CEO of Money Trade Coin Group and Mohammed Al Jariri, Director of Companies, Private office of His Highness Sheikh Ahmed Bin Obaid Al Maktoum along with other dignitaries (Photo: AETOSWire) The launch event, held April 15, 2018 at Burj Al Arab, was witnessed by the managements of the Private Office and Al Kasir Group. The guests included Shehab Bin Nouri, Walid Bin Nouri and Mohammed Aljariri. India's leading economist Dr Sharad Koli and 40 other VIPs. Over 140 members of the Press from across the globe were also present. Al Ka
Panasonic Is Exhibiting Latest Connected Supply Chain Solutions for Industry 4.0 Realization at CeMAT 2018 Trade Fair in Germany25.4.2018 18:50 | Tiedote
Panasonic Corporation is exhibiting its full range of logistics solutions at CeMAT 2018, the world's leading trade fair for the intralogistics and supply chain management sector, which is being held from April 23-27 in Hannover, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180425006197/en/ The Panasonic booth at CeMAT 2018 (Photo: Business Wire) [Video] Highlights of Panasonic at #CeMAT Supply Chain Solutions - Gemba Process Innovation https://youtu.be/oQq2EEjNSAs At its booth (Hall 20 / Stand C73), Panasonic is using live demonstrations and video displays to introduce its full line of solutions which maximize operational efficiency at each step of the supply chain from labeling and dispatch error detection at factories, to sorting and loading at distribution centers, on to transportation and proof of delivery. A video display at the front of the booth illustrates the flow of logistics information and material tra
Smithers Viscient Europe Appoints Jane Gray as Senior Manager, Terrestrial Ecotoxicology25.4.2018 18:42 | Tiedote
Smithers Viscient, a global contract research organization (CRO), today announced the appointment of Jane Gray to the position of Senior Manager, Terrestrial Ecotoxicology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180425006181/en/ Jane Gray, Senior Manager, Terrestrial Ecotoxicology at Smithers Viscient (Photo: Business Wire) Gray joins Smithers as a highly experienced Terrestrial Ecotoxicologist with over 17 years of CRO experience. Gray will oversee the management of a multidisciplinary team and lead the introduction of new study types as well as the design and conduct of guideline and non-standard studies to meet specific sponsor and regulatory objectives. “We are very excited to have Jane join our team as we continue to expand the Terrestrial team and grow our business in Harrogate. Jane’s experience and skill set in non-target arthropods; non-target plant studies and a range of pollinator studies will be an invalu
Munich Re: VitalityLife wins prestigious 2018 Celent Model Insurer Award for Operational Excellence25.4.2018 16:00 | Tiedote
Munich Re Automation Solutions Ltd. has announced that its long-established client, VitalityLife, has been recognized in Celent’s 2018 Model Insurer awards for its exemplary work in re-writing the rules of underwriting to achieve operational excellence. VitalityLife was rewarded for its novel use of technology in its Vitality Nurse initiative, reducing the time needed to fix underwriting terms for a life cover application from an average of 14 working days to as little as two hours. This initiative deploys a new team of Vitality nurses, equipped with the powerful third party data processor ALLFINANZ Evidence Analyzer from Munich Re. The nurse visits the client at home, carries out the blood test and enters their medical screening results directly into the ALLFINANZ Evidence Analyzer on their iPad, producing an immediate underwriting result. “We’re well known for our innovative products which are rooted in a culture of creativity and a desire to do what’s best for society” said Deepak J
EURid Announces the 2018 .eu Web Awards Launch25.4.2018 15:52 | Tiedote
The .eu Web Awards is an online competition, designed to acknowledge the best websites, using the .eu or .ею extensions, in five diverse categories. Anyone, who is eligible according to the .eu Web Awards rules can nominate their favourite .eu or .ею. website. This includes .eu and .ею domain name holders themselves, who can nominate their very own website for participation in the .eu Web Awards. “Our goal with the .eu Web Awards is to enhance the visibility of innovative, beautiful, and impactful .eu and .ею websites”, commented Giovanni Seppia, EURid External Relations Manager. The 15 finalists will be invited to the .eu Web Awards gala, held in Brussels on 21 November 2018, where the 5 winners – one per category - will be announced. The winners will receive a prestigious award package, including a two-month billboard advertising campaign in Brussels Airport, a custom 1-minute video produced by EURid for their promotional purposes, a custom trophy and personalised certificate. The 20
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