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
SMBC and Toshiba Jointly Develop New Equity Indices Using Advanced Quantum-Driven Technologies28.5.2026 04:00:00 EEST | Press release
Sumitomo Mitsui Banking Corporation (“SMBC”) and Toshiba Corporation (“Toshiba”) today announced the joint development of the SMBC/TOSHIBA Quantum Driven Diversified Japan Equity Index and the SMBC/TOSHIBA Quantum Driven Diversified U.S. Equity Index, new equity indices realized with advanced quantum-driven technologies. Collectively, the indices are referred to as “SMBC/TOSHIBA Quantum Diversified” (the “Indices”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260519448161/en/ Toshiba’s Simulated Bifurcation Machine 1. Background and Objectives Equity investment is central to asset management, but it also carries the ever-present risk of abrupt and substantial market fluctuations driven by geopolitical developments, changes in economic policy, and other external factors. In uncertain markets, investors are constantly seeking innovations in risk diversification that can protect their assets from unexpected market shocks. SM
BeOne Medicines Announces Phase 3 HERIZON-GEA Data Published in NEJM and Presented at ASCO 202628.5.2026 00:00:00 EEST | Press release
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that data from HERIZON-GEA-01 were published in The New England Journal of Medicine and will be presented in an oral presentation (Rapid Oral Abstract: 4010) at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2026, in Chicago.The HERIZON-GEA-01 clinical trial evaluated ZIIHERA® (zanidatamab) plus chemotherapy, with and without TEVIMBRA® (tislelizumab), compared with the control arm of trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ gastroesophageal adenocarcinoma (GEA). Dr. Sun Young Rha, Professor of Medical Oncology at the Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea, senior author of the NEJM manuscript and first author of the ASCO abstract, said: “Results from the HERIZON-GEA-01 published in The New England Journal of Medicine and presented in an oral presentation at ASCO provide ne
Stallergenes Greer Foundation Celebrates Excellence in Allergy Innovation With 2025 Awards27.5.2026 18:22:00 EEST | Press release
The Stallergenes Greer Foundation, dedicated to advancing allergy research, fostering innovation and addressing environmental factors which impact allergies, is delighted to announce the recipients of the 2025 edition of its prestigious Science Awards for Allergy. Building on the success of the previous edition, this year’s awards recognise outstanding contributions to allergy research and patient engagement and allocate a total of €100,000 to support these initiatives. Four researchers have been selected by the Board as award recipients, each receiving €25,000 across two categories: Innovation In Treatment Awards Assoc. Professor Alexander Eggel, PhD, Department for Biomedical Research, University of Bern, and Department of Rheumatology and Immunology, University Hospital Bern, Switzerland, recognised for his research: “Improving diagnostic and therapeutic options for allergic patients”; Dr Janice A. Layhadi, PhD, Research Associate, National Heart and Lung Institute, Imperial College
Capchase Secures $200M+, as Demand for Vendor Financing in Enterprise Tech Deals Accelerates27.5.2026 17:00:00 EEST | Press release
Capchase, the leading vendor financing platform for enterprise tech, today announced $200M+ in incremental funding to scale its embedded financing infrastructure globally and deploy more AI-enabled features. The funding, a mix of debt warehouse facilities and equity backed by institutional investors, reflects market validation that vendor financing has become essential infrastructure for enterprise technology companies to sell hardware and software products. As global B2B buyers face tighter budgets and greater scrutiny over large, up-front purchases, financing demand is growing. The Market Shift: Financing as a Growth Lever for B2B Tech Companies The $1.3 trillion vendor financing market has been traditionally dominated by banks and other lenders that utilize multi-thread email chains to manual doc review for underwriting. Capchase replaces those bottlenecks with financing tech embedded directly into sales tools such as Salesforce, enabling 97% of lending applications to be vetted and
ClickHouse Tops $250M ARR and 4,000 Customers, Launches Claude-Powered Agents at Open House 202627.5.2026 16:00:00 EEST | Press release
ClickHouse today opened Open House 2026, its second annual user conference, with a set of announcements that mark one of the company's most active quarters since founding. ClickHouse’s serverless cloud offering has crossed over $250 million in annual run-rate revenue — more than triple a year ago — and added more than 1,000 net new customers since January, bringing its total to 4,000. To meet the demands of AI-era workloads, the company also launched ClickHouse Agents, a fully managed agentic analytics service powered by Anthropic's Claude; published CostBench, an open benchmark comparing the major cloud data warehouses on cost-performance; and introduced House Mates, its first formal partner program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260527813115/en/ ClickHouse Co-Founders (left to right): Yury Izrailevsky, Aaron Katz, Alexey Milovidov Growth When ClickHouse closed its $400 million Series D in January 2026, it
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