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
Royal Moroccan Football Federation Acknowledges Decision Rendered by the CAF Appeals Committee18.3.2026 19:49:00 EET | Press release
The Royal Moroccan Football Federation (FRMF) wishes to reiterate that its appeal was never aimed at contesting the sporting merit or performance of the teams involved in this tournament, but solely to ensure the proper enforcement of competition regulations. The federation reaffirms its commitment to respecting the regulations, ensuring the clarity of the competitive framework and maintaining the stability of African football competitions. The Federation also wishes to commend all the nations that participated in this year’s edition of the Africa Cup of Nations (AFCON), which served as a significant moment for African football. The FRMF will issue a more comprehensive official statement in the coming days after a scheduled meeting of its governing bodies. Source: AETOSWire View source version on businesswire.com: https://www.businesswire.com/news/home/20260318763307/en/
SIMCON Unveils World’s First Large Engineering Model for Plastic Injection Moulding18.3.2026 19:05:00 EET | Press release
SIMCON today announced the launch of the Cadmould AI Solver, the world’s first Large Engineering Model for injection moulding. Co-developed with Emmi AI, the new transformer-based architecture delivers simulation results up to 1000 times faster than traditional numerical solvers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260318680159/en/ SIMCON’s new Cadmould AI Solver delivers injection molding simulation results in seconds. By removing lengthy computation times, the tool enables engineers to dynamically explore thousands of design and process variations in a single day. Historically, lengthy computation times have acted as a bottleneck, limiting the number of design variations engineers can practically explore during the development process. The Cadmould AI Solver shatters this barrier by providing engineers with instant feedback on filling pattern, pressure, and temperature in seconds. What once required hours per si
Boomi, a 12X Leader, Positioned Highest for Ability to Execute in the 2026 Gartner® Magic Quadrant™ for Integration Platform as a Service18.3.2026 17:30:00 EET | Press release
Boomi™, the data activation company, today announced it has been recognized as a Leader and positioned highest for Ability to Execute in the 2026 Gartner® Magic Quadrant™ for Integration Platform as a Service (iPaaS). This marks the 12th consecutive time Boomi has been named a Leader– the longest recognized vendor in the report’s history. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260318987091/en/ Boomi, a 12X Leader, Positioned Highest for Ability to Execute in the 2026 Gartner® Magic Quadrant™ for Integration Platform as a Service Boomi attributes its continued industry recognition to its unwavering commitment to innovation, customer success, and ecosystem growth. Over the past year, Boomi has accelerated its investments in integration and automation, APIM, agent management, and data management to help enterprises transform fragmented systems and data into orchestrated processes and governed agentic workflows. Recent i
Torq Becomes the Cursor of Security Operations With New Agentic Builder18.3.2026 16:47:00 EET | Press release
Torq, the established agentic security operations leader, today unveiled Agentic Builder, a critical extension of the Torq AI SOC Platform that turns human intent into agentic outcomes. Agentic Builder enables SOCs to shift the cognitive load of engineering security automation from humans to machines. These Cursor-level capabilities eliminate all barriers to deliver production-grade agentic workflows and AI Agents that manage unlimited alerts 24x7, integrate with every level of the enterprise stack, streamline investigation, and respond at machine speed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260318328878/en/ This news follows Torq’s recent announcement that it has secured a $140M Series D round at $1.2B valuation to lead the AI SOC and Agentic AI era. Torq AI Agents are now deeply embedded in the daily operations of Fortune 500 SOCs, managing millions of complex security tasks autonomously. Torq now protects hundred
Laserfiche Announces 2026 Run Smarter® Award Winners18.3.2026 16:17:00 EET | Press release
Laserfiche — the leading SaaS provider of intelligent content management — today announced the winners of the 2026 Laserfiche Run Smarter® Awards. These awards celebrate the visionaries and trailblazers who are redefining the possible, using Laserfiche to break down operational silos and catalyze a new era of enterprise-wide productivity. From a large city reimagining criminal justice to a financial services firm’s innovative use of AI for smarter service delivery: The winners enhance productivity, reimagine processes and improve lives with Laserfiche technology. “The true power of Laserfiche has always been in how it unlocks value — whether that is through delivering actionable intelligence, cost savings, or reclaimed time to put toward innovation,” said Karl Chan, CEO of Laserfiche. “This year’s honorees are at the forefront of information management, with many of them leveraging cloud and AI technology to modernize processes and achieve business transformation.” Congratulations to t
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