Boehringer Ingelheim announces European Medicines Agency’s filing acceptance and validation of marketing authorization application for spesolimab in generalized pustular psoriasis
Boehringer Ingelheim announced today that the company’s marketing authorization application (MAA) for the treatment of flares in generalized pustular psoriasis (GPP), has been validated and is now under evaluation with the European Medicines Agency (EMA).
“GPP is a rare, life-threatening neutrophilic skin disease characterized by painful, sterile pus-filled blisters, that can suddenly appear over the body,” said Dr. Janine Lamar, Global Spesolimab Lead at Boehringer Ingelheim. “Despite its name, GPP is very different to the more common plaque psoriasis. With no approved treatments in the EU for GPP flares, acceptance of the application for review of spesolimab brings us one step closer to providing a targeted treatment for people with this distressing, unpredictable and painful skin condition.”
GPP is characterized by episodes of widespread eruptions of painful, sterile pustules (blisters of non-infectious pus).1,2,3 The inflammation can also affect other parts of the body and can lead to infections or other organ complications that may be life-threatening.
There is a high unmet need for treatments that can rapidly and completely resolve the symptoms of GPP flares. Flares greatly affect a person’s quality of life4 and can lead to hospitalization with life-threatening complications, such as heart failure, renal failure, sepsis and even death.5
The marketing authorization application was based on the 12 week Effisayil-1 trial; a multi-center, double-blind, randomized, placebo-controlled trial that evaluated efficacy, safety, and tolerability of spesolimab (single dose 900 mg spesolimab i.v., with the option of a 2nd dose if symptoms persisted on Day 8) in patients experiencing a GPP flare.6 The study demonstrated superiority over placebo in pustular clearance after one week of treatment.
Please click on the following link for ‘Notes to Editors’:
http://www.boehringer-ingelheim.com/press-release/ema-filing-acceptance-and-validation-spesolimab
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211029005027/en/
Contact information
Boehringer Ingelheim
Corporate Communications
Media + PR
Dr Julia Faass
Phone: +49 (6132) 77 95614
Fax: +49 (6132) 77 6601
Email: press@boehringer-ingelheim.com
Additional information
www.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
Dilawer Farazi Returns to Loomis Sayles as Co-Head and Portfolio Manager on the Emerging Markets Debt Team17.11.2025 17:59:00 EET | Press release
Loomis, Sayles & Company is pleased to announce that Dilawer Farazi, ACA, has rejoined the firm as Co-Head and Portfolio Manager of the Emerging Markets Debt (EMD) Team. Dilawer becomes the firm’s first London-based portfolio manager. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117681347/en/ Dilawer Farazi, ACA, has rejoined Loomis Sayles as Co-Head and Portfolio Manager of the Emerging Markets Debt Team Dilawer brings over two decades of experience in emerging markets credit, having previously served as a Senior Credit Research Analyst at Loomis Sayles from 2018 to 2020. He rejoins the firm from Royal London Asset Management (RLAM), where he led the Emerging Markets Credit team and managed approximately USD $1 billion in assets across EM credit. At RLAM, he launched the firm’s first dedicated emerging markets funds, including an emerging markets corporate bond fund and an emerging markets short duration credit fund. I
Duravant Announces Retirement of CEO Mike Kachmer, Names Jill Evanko Successor17.11.2025 17:13:00 EET | Press release
Duravant LLC (“Duravant”), a global leader in advanced automation solutions, announced today that Mike Kachmer will retire from his role as Chief Executive Officer after a highly successful tenure with the company. Duravant’s Board of Directors has named Jill Evanko as CEO, joining the company on January 5, 2026. To ensure a seamless transition, Mr. Kachmer will continue to serve as Chairman of Duravant. Mr. Kachmer will also continue to serve on the Board of Directors for Northwestern Memorial Healthcare and The London Clinic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117036720/en/ Mike Kachmer “It has been a true honor and a humbling experience to lead this incredible company,” said Mr. Kachmer. “I am profoundly grateful to my colleagues within Duravant for their support over the years. Together, we have built an organization with a truly differentiated operating model and culture, one that cultivates collaboration
Morningstar's 2026 Outlook Report Delivers Global and Regional Insights for Durable Portfolios17.11.2025 16:00:00 EET | Press release
Morningstar, Inc. (Nasdaq: MORN), a leading provider of independent investment insights, today published its 2026 Outlook, offering an overview of key challenges and opportunities for the year ahead. In a market defined by uncertainty, this year’s report emphasizes the value of preparation over prediction, equipping investors with strategies to focus on fundamentals and help build resilient portfolios that withstand both booms and busts. Drawing on insights from Equity, Manager, and Behavioral research analysts worldwide, this Outlook distills Morningstar’s thinking on how to navigate opportunity and risk across every major asset class in 2026. "Markets are unpredictable, and the geopolitical and tariff uncertainty of 2025 showed just how quickly forecasts can shift. That’s why Morningstar is redefining the Outlook, focusing on durable portfolios rather than short-term predictions,” said Dan Kemp, chief research and investment officer. “No matter what market conditions the year ahead m
Wolters Kluwer Enablon Control of Work Solution Now Available as Private Offer in AWS Marketplace17.11.2025 16:00:00 EET | Press release
Wolters Kluwer today announced that its Enablon Control of Work solution is now available in AWS Marketplace as a private offer. This purchasing model empowers customers to negotiate and receive tailored pricing, terms, and licensing agreements, while streamlining procurement and leveraging existing Amazon Web Services (AWS) billing workflows to accelerate deployment and optimize cloud budgets. Wolters Kluwer’s Enablon Control of Work solution consolidates permit-to-work, isolation management and risk assessments into an integrated system. Trusted by frontline workers and contractors in high-risk environments including oil & gas, pharmaceuticals, data center and manufacturing industries, the software helps streamline operations, minimize unplanned downtime and prevent serious injuries and fatalities. Richard Pulliam, SVP & General Manager of EHS & ESG for Wolters Kluwer, said: “Making Enablon's Control of Work solution available in AWS Marketplace is another step in our mission to help
World First: Autonomous Racing Leaps Forward in Abu Dhabi as A2RL Season 2 Showcases Record Speed, Bold Overtakes and Real-Time AI Decision-Making17.11.2025 15:50:00 EET | Press release
The Abu Dhabi Autonomous Racing League, A2RL, delivered a defining moment for autonomous technology as six fully driverless racecars pushed the limits of AI performance in a world-first Grand Final at Yas Marina Circuit. In a night marked by record speed, bold overtakes, and split-second AI decision-making, Germany’s TUMcemented its dominance by retaining the championship title, followed by TII Racing (UAE) in second place, and PoliMOVE (Italy) in third. With eleven international teams battling for a $2.25 million prize pool and a Human vs AI showdown featuring former F1 star Daniil Kvyat, the event showcased just how dramatically the race - and the technology behind it - has advanced since Season 1. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117644875/en/ World First: Autonomous Racing Leaps Forward in Abu Dhabi as A2RL Season 2 Showcases Record Speed, Bold Overtakes and Real-Time AI Decision-Making (Photo: AETOSWire
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