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
Winston Taylor Completes Historic Transatlantic Combination1.6.2026 14:01:00 EEST | Press release
Winston Taylor announces today that Winston & Strawn and Taylor Wessing’s U.K.-led business have officially launched as a single combined firm, creating a premier transatlantic law firm built for the needs of the businesses, people, and markets driving capital and innovation. One of the largest transatlantic firms, with more than 1,400 lawyers spanning the United States, the United Kingdom, Europe, Latin America, and the Middle East, Winston Taylor is built to meet clients’ evolving global needs for counsel. “As Winston Taylor, we are centered on a client-first approach and will be working shoulder to shoulder with our clients at the cutting edge of industry and ingenuity,” said Chairman Steve D’Amore. “With that common purpose, we are leveraging both strength and scale by integrating our teams and offices at record speed, working at pace to create a firm that is aligned, focused, and built for the day-to-day needs of our clients as well as their breakthrough moments.” Winston Taylor o
Kinaxis Appoints Kristin Russel as Chief Marketing Officer1.6.2026 14:00:00 EEST | Press release
Kinaxis® Inc. (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, today announced the appointment of Kristin Russel as Chief Marketing Officer (CMO). Russel will lead Kinaxis’ global marketing organization, overseeing marketing strategy, corporate and market positioning, digital and brand marketing, communications and go-to-market initiatives. Russel will also take the main stage at Kinexions, where she will discuss practical steps organizations can take to move from decisions to outcomes in an increasingly complex operating environment. A tenured marketing executive and recognized industry leader, Russel brings deep experience scaling technology companies and building high impact brands. She joins Kinaxis from symplr, where she served as Chief Marketing Officer and led the development and execution of the company’s comprehensive marketing strategy across branding, digital and product marketing, public relations, community outreach programs, channel partne
Samsung Electronics Begins Shipment of Industry-First HBM4E Samples1.6.2026 13:57:00 EEST | Press release
Samsung Electronics, a global leader in advanced memory technology, has begun shipping the industry's first 12-layer HBM4E samples to major global customers, further strengthening its leadership in the next-generation HBM market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260601979564/en/ Samsung's 12-layer HBM4E Following the industry’s first mass production and commercial shipment of its industry-leading HBM4 earlier this year, Samsung now extends its HBM roadmap with the introduction of HBM4E samples, addressing the rapidly evolving demands of AI computing and hyperscale infrastructure. "Following the successful mass production of HBM4, Samsung has once again demonstrated its distinct technological edge with HBM4E," said Sang Joon Hwang, Executive Vice President and Head of Memory Development at Samsung Electronics. "Through our advanced manufacturing capabilities and preemptive infrastructure investments, we will con
GIGABYTE Showcases Full-Stack AI Infrastructure from Rack-Scale Systems to Real-World Deployment at COMPUTEX 20261.6.2026 13:30:00 EEST | Press release
Following the introduction of its "Future Landing" vision, GIGABYTE Technology, a global leader in high-performance computing and AI infrastructure, brings that vision to life at COMPUTEX 2026 through a comprehensive showcase of systems, software, and real-world deployments that demonstrate how AI infrastructure is built, deployed, and operated at scale. From rack-scale AI factories and modular data centers to Physical AI workflows, clinical AI applications, and on-prem AI agents, GIGABYTE demonstrates how AI infrastructure moves beyond planning and into production. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260525486787/en/ Rack-Scale Infrastructure, Validated for AI Factories At the foundation of “Future Landing” is GIGABYTE’s expanding portfolio of rack-scale AI infrastructure designed for next-generation AI factories. Among the latest highlights is the NVIDIA Vera Rubin NVL72, showcased as part of GIGABYTE’s broader
BeOne Medicines Highlights Accelerating Solid Tumor Pipeline with New Data at ASCO 20261.6.2026 13:00:00 EEST | Press release
BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data from its solid tumor pipeline being presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29–June 2, Chicago). These data underscore the significant acceleration across the Company’s high-priority breast, gynecologic and gastrointestinal (GI) cancer development programs. Data from three differentiated BeOne pipeline assets will be presented, including: CDK4 inhibitor (BGB-43395) (poster presentation): First disclosure of anti-tumor activity in first-line (1L) HR+/HER2- metastatic breast cancer. B7-H4 ADC (BG‑C9074) (rapid oral presentation): Phase 1 dose-escalation and safety expansion data in advanced solid tumors. GPC3x4-1BB (BGB-B2033)bispecific antibody (rapid oral presentation): First clinical data in advanced solid tumors, including hepatocellular carcinoma (HCC), the most common type of liver cancer. Mark Lanasa, M.D., Ph.D.
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