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
GigaDevice Deepens Ecosystem Collaboration with LVGL to Advance GD32’s Global Open-Source GUI Ecosystem12.10.2026 16:00:00 EEST | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, is deepening its ecosystem collaboration with LVGL. LVGL's Open graphics library is one of the world’s most widely‑adopted open‑source embedded frameworks. Eight GD32 MCU product families have now been officially included in the LVGL ecosystem, providing developers worldwide with more convenient and efficient support for embedded graphics development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261012320702/en/ Eight GD32 product series supported on LVGL website LVGL is an open-source graphical user interface framework designed for embedded devices, commercially supported by LVGL Ltd., a technology company based in Cambridge, UK. Lightweight, efficient, and cross-platform, it can be widely used in applications such as smart home devices, industrial control systems, consumer electronics, a
W. L. Gore & Associates Launches GORE® Battery Vents – MultiVent Series at the Battery Show12.10.2026 15:00:00 EEST | Press release
Today, W. L. Gore & Associates (Gore) introduced GORE® Battery Vents – MultiVent Series at The Battery Show North America 2026, a new integrated venting architecture that combines all three functions into a single device. Designed for lithium-ion battery packs in electric vehicles and energy storage systems, GORE® MultiVent is an integrated battery vent: one device that equalizes pressure, protects against moisture and evacuates gas during thermal runaway, then reseals. It gives pack designers an alternative to combining dual-stage vents, separate evacuation valves and desiccants. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261012625188/en/ GORE® MultiVent GORE MultiVent builds on technology Gore acquired from Vernay Laboratories in 2026 and combines Gore membrane expertise with Vernay’s advanced valve technology. Battery pack designers have traditionally relied on multiple components to manage pressure equalization, mois
Echodyne and ACS Sign Strategic Collaboration Agreement to Advance Counter-UAS Capabilities Worldwide12.10.2026 15:00:00 EEST | Press release
Echodyne, the radar platform company, and ACS, a precision robotics company for defense, today announced the signing of a Strategic Collaboration Agreement to accelerate the development, demonstration, and deployment of integrated counter-unmanned aircraft system (C-UAS) solutions. The agreement establishes collaboration across Echodyne’s high-performance commercial counter-UAS radar hardware and software roadmaps and ACS’s Bullfrog robotic weapon station capabilities, and follows the recent announcement of each company’s award from Joint Interagency Task Force 401 for Domestic Shield, the JIATF-401 C-UAS Marketplace, and other critical counter-drone requirements. Bullfrog combines computer vision, autonomous control, and precision robotics with existing weapon systems to detect, track, identify, and engage unmanned threats. Integrating Echodyne’s precise radar track data extends this capability with persistent airspace positional information, providing earlier awareness and high-confi
Doctors, Public Health Experts and Dental Leaders Call for Oral Health to Become Part of Everyday Health Care12.10.2026 14:34:00 EEST | Press release
Doctors, public-health experts and dental leaders are calling for oral health to be treated as part of overall health. Their message is clear: healthier teeth and gums matter beyond the mouth, and effective daily prevention should become a routine part of health care. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015403348/en/ Oral health is part of overall health. Leading health experts are calling for oral health to become part of everyday health care, with prevention starting at home through healthier habits and daily care of teeth and gums. The new international consensus goes well beyond dentistry. It brought together experts in periodontology, cardiology, diabetes care, family medicine, public health, social care and health education. Convened by the European Federation of Periodontology (EFP) and the European Association of Dental Public Health (EADPH), the group calls on governments, health systems and health pro
Pacific Defense Launches NEXUS, a Converged C2 and Electromagnetic Warfare Mission System12.10.2026 14:30:00 EEST | Press release
Pacific Defense, a leading provider of open-architecture C5ISR and electronic warfare mission systems, today announced the launch of NEXUS, a Commercial Off-the-Shelf (COTS) mission system that converges command and control, communications, networking, edge computing, and electronic warfare on a common, adaptable architecture. Built on a Modular Open Systems Approach (MOSA) aligned to SOSA™, CMOSS and OpenVPX™, NEXUS enables mission-specific configurations across mobile, fixed-site, maritime, and airborne operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261012010656/en/ NEXUS converges EW and C5ISR in one, open-architecture system for missions across ground, maritime, and airborne operations. NEXUS brings capabilities traditionally integrated through separate systems onto a common chassis, power, timing, processing, and networking foundation, providing shared infrastructure for C2 and EW mission capabilities. One A
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