BOEHRINGER-INGELHEIM
29.10.2021 09:02:12 CEST | 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20211029005027/en/
About Business Wire
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
Doha Debates Podcast Returns for a New Season Exploring the Ideas Shaping Our World23.9.2026 19:29:00 CEST | Press release
The 20-episode season, launched September 22, builds on questions raised in flagship debates and global town halls through long-form conversations. Qatar Foundation’s Doha Debates has launched a new season of the Doha Debates Podcast, with 20 episodes airing weekly through February 16, 2027. The series brings leading global thinkers together to debate some of the world’s most complex and challenging issues. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260923050361/en/ Doha Debates Podcast Returns for a New Season (Photo: AETOSWire) The podcast carries forward themes from its flagship debates and town halls through long-form conversations, reflecting Doha Debates’ commitment to open, truth-seeking dialogue exploring global issues with depth, nuance and respect for diverse perspectives. The opening episode, “Will China or the West lead the world into the future?” moderated by Soraya Salam, brings together Renata Ávila, CEO o
Dryad Wins International XPRIZE Wildfire Award for Autonomous Wildfire Detection and Suppression23.9.2026 19:00:00 CEST | Press release
European finalist demonstrates ultra-early wildfire detection with Silvanet and autonomous suppression with Silvaguard Dryad Networks, a leader in ultra-early wildfire detection, today announced it has been awarded $800,000 in the XPRIZE Wildfire competition for its performance in the Autonomous Wildfire Response finals in Alaska. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260923024178/en/ Silvaguard Observation and Suppression drone and Hangar Dryad advanced from an original field of approximately 300 entrants in the four-year competition. In June 2026, three finalists were challenged to autonomously detect and completely suppress a high-risk wildfire within 10 minutes of ignition across 1,000 km² of Alaskan wilderness, leaving any decoy fires untouched. It was the most demanding live test to date of what it will take to stop a destructive fire before it grows out of control. During the tests, the Dryad’s Silvanet senso
SES Appoints Michel Scholer to Board of Directors23.9.2026 18:54:00 CEST | Press release
Michel brings extensive leadership, governance and strategic policy experience through his roles with the Luxembourg government SES today announced the appointment of Mr. Michel Scholer, Secretary General of the Luxembourg Government and Chief of Staff to the Prime Minister, to its Board of Directors effective immediately. This appointment is part of SES’s Board succession planning and ongoing commitment to regularly review and strengthen the composition of its Board with diverse expertise and industry experience, ensuring the company is well positioned for future growth and value creation. Prior to his current role with the Luxembourg Government, Mr. Scholer served as a Senior Adviser to the International Monetary Fund, and with the Ministry of Finance, Luxembourg. He was nominated for the SES Board of Directors by the Government of the Grandy Duchy of Luxembourg. Follow us on: LinkedIn | Facebook | YouTube | X | Instagram Read our Blogs > Visit the Media Gallery > About SES At SES, w
Future Health - A Global Initiative by Abu Dhabi: New Analysis Estimates Modifiable Health Risks Represent $16.4 Trillion Annual Global GDP Opportunity in 205023.9.2026 18:50:00 CEST | Press release
A new whitepaper by Future Health – A Global Initiative by Abu Dhabi, in collaboration with the McKinsey Health Institute, estimates that eliminating modifiable health risks could deliver substantial health and economic benefits Under a full risk-elimination scenario, annual global GDP could be USD 16.4 trillion higher in 2050, equivalent to 9% of projected global GDP Analysis finds that eliminating modifiable behavioural, metabolic and environmental risk factors could avert an estimated 1.5 billion disability-adjusted life years (DALYs) globally and add 12 years to global healthy life expectancy at birth in 2050 The 1.5 billion DALYs are equivalent to approximately 47 percent of projected global disease burden in 2050 The whitepaper sets out a five-step framework for governments to turn healthy-living ambitions into coordinated action, presenting Abu Dhabi’s Healthy Living Strategy as a practical example of government-wide, whole-of-society delivery Addressingbehavioural, metabolic an
SES Confirms Interim Dividend of EUR 0.2523.9.2026 18:46:00 CEST | Press release
Interim dividend approved as part of SES’s continued commitment to shareholder returns intended to be at least EUR 0.50 total dividend for FY2026 The SES Board of Directors has approved the payment of an interim dividend of EUR 0.25 per A-share (EUR 0.10 per B-share) to be paid to shareholders on October 15, 2026, in line with SES’s commitment to shareholder returns. The interim dividend to be paid in October 2026 will be followed, subject to financial results and shareholder approval, by the payment of a final dividend of at least EUR 0.25 per A-share (EUR 0.10 per B-share) in May 2027. Follow us on: LinkedIn | Facebook | YouTube | X | Instagram Read our Blogs > Visit the Media Gallery > About SES At SES, we believe that space has the power to make a difference. That’s why we design space solutions that help governments protect, businesses grow, and people stay connected—no matter where they are. With integrated multi-orbit satellites and our global terrestrial network, we deliver res
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