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
INNIO Secures 450 MW Order to Power Next-Generation Data Centers17.9.2026 15:30:00 EEST | Press release
INNIO N.V. (Nasdaq: INIO) today announced it has secured an order from a U.S. energy company for 450 megawatts (MW) of power infrastructure. INNIO's Jenbacher J624 containerized gas engines will support the deployment of prime power solutions for large-scale data center projects in North America. The order reflects continued demand for the company's high-efficiency gas engine technology as data center developers seek off-grid alternatives to constrained grid infrastructure. This is the first order by the customer of this scale. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260917646026/en/ INNIO secures 450 MW order to power next-generation data centers The engines are expected to be delivered by 2028. The firm order was booked in INNIO’s current third quarter of 2026.In line with customary confidentiality practices in the data center industry, the energy company’s name is not being disclosed at this time. "AI is driving un
Adtran showcases open optical networking for AI infrastructure at OIF’s ECOC 2026 interop demo17.9.2026 15:00:00 EEST | Press release
Adtran today announced its participation in OIF’s live multi-vendor interoperability demo at ECOC 2026, taking place September 21 to 23 in Málaga, Spain. Bringing together 39 member companies, the showcase highlights interoperable optical transport, pluggable coherent transceivers and network control technologies in a multi-vendor environment. Adtran is contributing 100Gbit/s, 400Gbit/s and 800Gbit/s ZR+ pluggables, its FSP 3000 open line system (OLS) operating across C- and L-bands and Mosaic Network Controller software. Ahead of the event, Adtran also hosted the OIF test run in Gdynia, Poland, supporting interoperability testing across participating companies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260917984277/en/ Adtran’s technology will help show how interoperable networks can meet AI’s surging capacity demands at OIF’s ECOC 2026 demo. “AI-driven demand is putting huge pressure on networks to scale, but operator
EdgeConneX Appoints SVP of Global Construction Delivery, Vice Presidents for Norway and Germany17.9.2026 14:00:00 EEST | Press release
EdgeConneX®, a global leader in Build-to-Suit and Build-to-Density digital infrastructure solutions, today announced the appointments of Garry O’Leary as SVP, Delivery, Global, Anders Hilt as Vice President of Norway, and Michael Barth as Vice President of Germany. All three hires bring a deep commitment to building strong local relationships and will play a key role in advancing the company's global projects and supporting community engagement and local support efforts. EdgeConneX continues to expand its platform globally, with gigawatts of major projects underway across multiple continents. As SVP, Delivery, Global, Garry plays a critical role in delivering the company's new capacity on time and on budget, overseeing regional construction leadership, contractor and vendor management, site safety, quality assurance, and supply chain. Prior to joining EdgeConneX, Garry was Vice President and Director of Construction Delivery (EMEA) at Compass Datacenters, where he led complex global de
IFF Launches Omni-Bos™ PHY to Help Dairy Producers Get More Value from Feed17.9.2026 14:00:00 EEST | Press release
IFF (NYSE: IFF) — a global leader in flavors, fragrances and health and biosciences — today announced the launch of Omni-Bos™ PHY, a novel phytase enzyme designed specifically for dairy cattle. The technology helps producers improve nutrient utilization and feed efficiency by unlocking nutrients already present in feed, enabling cows to derive greater value from existing feed ingredients. Omni-Bos™ PHY will initially launch in the Middle East, Africa and Asia-Pacific regions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260916599752/en/ IFF has launched Omni-Bos™ PHY, a phytase enzyme developed specifically for dairy cattle, that helps producers unlock nutrients already present in feed to improve nutrient utilization and feed efficiency. “We believe the future of dairy nutrition is helping cows receive more value from the nutrients in their feed,” said Regina Cortada, vice president, Animal Nutrition & Health for IFF Healt
Brushing Well Is Harder Than Most People Think — New Research Confirms Why the Technology Behind Oral-B iO is the Best Way to Help You Get it Right17.9.2026 13:40:00 EEST | Press release
Oral-B, the #1 toothbrush brand used and recommended by dentists worldwide, today announced new evidence reinforcing the superiority of Oral-B iO technology. In an independent 2026 peer-reviewed network meta-analysis of 19 randomized clinical studies involving more than 1,300 participants, the oscillating-rotating technology behind Oral-B iO was ranked #1 for plaque removal and gingivitis reduction. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260911054017/en/ Oral-B iO9 makes a superior clean easier to achieve every day. Most people think they are brushing effectively, but brushing well is harder than it seems. Plaque often remains in the places that are hardest to clean, including along the gumline, between teeth and around molars. In fact, 80% of people miss at least one area when brushing, and 60% miss their molars. Over time, that plaque buildup can impact oral health and well-being. “People brush every day, but brush
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