Boehringer Ingelheim announces European Medicines Agency’s filing acceptance and validation of marketing authorization application for spesolimab in generalized pustular psoriasis
29.10.2021 10:00:00 EEST | Business Wire | Press release
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
Lincotek Appoints New Global General Manager for Its Medical Division7.4.2026 11:08:00 EEST | Press release
Lincotek today announced the appointment of Gianluca Fioravanti as Global General Manager of its Medical Division - a global solution provider for the orthopedic market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407710572/en/ Gianluca Fioravanti, Global GM Lincotek’s Medical Division Reporting directly to Group CEO Andrea Colombo, Fioravanti assumed the role as of April 7 and will help drive the business forward. He will lead the development and execution of the company’s global growth strategy, while ensuring its seamless operational implementation across all regions. This strategic appointment reflects Lincotek’s commitment to enhance the value it delivers to customers, strengthening its ability to serve them better. Fioravanti brings more than 25 years of international experience to the Group, having held senior leadership roles across operations, engineering and general management in the medical sector. With a de
Toshiba’s Breakthrough Algorithm Harnesses Edge of Chaos to Dramatically Boost Performance of its Quantum‑Inspired Computer7.4.2026 10:00:00 EEST | Press release
Toshiba Corporation has developed a breakthrough algorithm that dramatically boosts the performance of the Simulated Bifurcation Machine (SBM), its proprietary quantum‑inspired combinatorial optimization computer. The new algorithm significantly improves the probability of obtaining an optimal solution or a known best solution within a limited number of trials—referred to as the success probability, a key benchmark for evaluating combinatorial optimization technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407918434/en/ Figure 1: Results demonstrating that the newly developed third‑generation SB algorithm can find the known best solution with nearly 100% probability at the edge of chaos for a fully connected 2,000‑spin Ising problem. The SBM is designed to solve large‑scale combinatorial optimization problems in a wide range of fields, including new drug discovery, delivery route optimization, and investment por
Budweiser Honors 40 Years of FIFA World Cup™ Legacy with Limited-Edition Collectible Pack and Nostalgia-Themed Platform7.4.2026 10:00:00 EEST | Press release
Today, Budweiser is celebrating 40 years as the Official Beer Sponsor of the FIFA World Cup™ with the launch of the largest limited-edition collectible pack ever – the Budweiser® FIFA World Cup™ Anniversary Pack* – bringing to life 11 bold design tributes to every tournament since 1986, and the centerpiece of a new nostalgia driven global platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407304059/en/ Budweiser® FIFA World Cup™ Anniversary Pack Throughout history, Budweiser has played an important role in some of football’s most unforgettable celebrations, from last-minute goals to trophy lifts seen around the world. These moments of “Budstalgia” [Budweiser + nostalgia] are the inspiration for the brand’s newest platform, brought to life through a new collectible design, a global film titled “The Big Drop,” distinctive out-of-home creative, and an era-inspired digital hub. “For 40 years, Budweiser has been part of
Ardabelle Reveals a €7 Trillion Challenge for Europe: Invest Now or Lose a Generation of Competitiveness7.4.2026 08:30:00 EEST | Press release
Europe is navigating a period of intense turbulence, where geopolitical crises, pressure on critical raw materials, and climate‑related shocks are reinforcing one another. This polycrisis is no longer cyclical: it is structurally reshaping the continent’s value chains and testing its industrial competitiveness. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260406787383/en/ Europe's Choice: €27T Coordinated Growth or €20T Fragmented Decline by 2050 In this context, Ardabelle is releasing Greening the Arteries of Industry, a groundbreaking study that quantifies for the first time the economic gap between a Europe that endures and a Europe that invests. Conducted under the scientific supervision of economist Xavier Jaravel, this work represents the first attempt to model, in an integrated way, industrial resilience, ecological transition, and European competitiveness through 2035 - 2050. The study was presented under the high
Tigo Energy Launches New GO Optimized Energy Storage System in European Residential Market7.4.2026 07:00:00 EEST | Press release
Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced availability of the Tigo GO Battery, a next-generation energy storage system and the latest addition to the Tigo GO optimized product line in Europe, joining the GO EV Charger and GO Junction for heat pump integration. The system delivers expandable energy storage capacity of up to 47.9kWh, faster installation via lightweight plug-and-play modules, and cold-weather operation down to -30°C. Installer preorders are currently available, with product shipping commencing in June 2026. The new GO Battery arrives as several European countries set new all-time single-day records for solar energy production, and global solar installations grew by 11% between 2024 and 2025. The Tigo GO Battery serves European market demand with an optimized modular architecture built on 3.68kWh battery units that installers can configure from 7.3kWh for compact installati
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