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
Footprint Expands Into PE-Free Cups, Bringing a Proven, Recyclable and Home-Compostable Alternative to Plastic-Lined Paper Cups Into Production21.7.2026 18:00:00 CEST | Press release
Move strengthens Footprint’s European manufacturing platform and supports growing demand for practical alternatives to single-use plastic Footprint, a materials science and technology company focused on eliminating single-use plastics, today announced it has acquired a recyclable, home-compostable, polyethylene (PE)-free hot and cold cup platform from Transcend Packaging, along with next-generation paper lid and straw solutions. Transcend Packaging is a European company focused on innovation in sustainable packaging solutions. Together, the cup, lid, and straw expand Footprint’s portfolio with a proven solution for the global cup market. Footprint will begin scaling its new PE-free solution through its Poland facility as the company expands across Europe, with North America to follow. As operations ramp in Poland, Footprint will work with Transcend through a manufacturing partnership to support customer continuity across Europe and meet growing demand for practical alternatives to plas
Spectro Cloud Launches PaletteAI Inference Launchpad to Reduce Enterprise Token Costs by up to 70%21.7.2026 16:00:00 CEST | Press release
New turnkey, locally managed PaletteAI Inference Launchpad helps enterprises control token costs with local-first inference, while expanded PaletteAI support for AMD gives customers more choice across GPUs, models and AI infrastructure stacks. Spectro Cloud, a leading provider of AI infrastructure management software, today launched PaletteAI Inference Launchpad, a turnkey, locally managed solution designed to help enterprises reduce token costs by as much as 70% and run AI inference closer to their data, applications and users. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721597271/en/ The company also announced expanded PaletteAI support for AMD-powered AI infrastructure, including AMD GPUs, AMD GPU Operator, ROCm™ runtime, and the AMD enterprise AI reference stack — including AMD-optimized models from the AMD Inference Microservices (AIMs) catalog. Together, the announcements expand PaletteAI as one platform for prod
RecVue Launches First AI Native Agentic Revenue Operating System21.7.2026 15:03:00 CEST | Press release
New agentic architecture for RevOS runs enterprise revenue across the order-to-cash lifecycle and surfaces cross-system intelligence RecVue, the leader in billing and revenue management solutions, today announced the evolution of RecVue RevOS into the industry's first Agentic Revenue Operating System. In an architectural shift, the now-native agentic revenue management platform moves revenue operations beyond AI-assisted workflows to fully governed, autonomous execution with more than 50 purpose-built agents that work across contracts, invoices and payment data to predict risk, surface anomalies and escalate exceptions throughout the quote-to-cash lifecycle. Enterprise revenue operations have long suffered from a structural gap between billing systems that generate invoices and ERP systems that record transactions. Finance teams face tedious, manual reconciliation month after month, often resulting in delayed cash, billing errors that generate disputes, revenue leakage from ungoverned
Yubico Extends Passkeys Beyond Trusted Authentication to Verified Authorization with Launch of YubiKey 5.821.7.2026 15:00:00 CEST | Press release
YubiKey 5.8 extends hardware-backed assurance from authentication into emerging digital signature, wallet, payment and agentic approval workflows Yubico (NASDAQ STOCKHOLM: YUBICO), the pioneer of phishing-resistant authentication and creator of the original passkey, the YubiKey, today announced the general availability of its YubiKey 5.8 – marking an expansion of the role of the passkey from secure authentication to include verifiable, hardware-backed authorization. The new firmware delivers a foundation for secure enterprise workflows across identity wallets, document signing, and AI-driven approvals, while also providing developers with the critical capabilities needed to test, design and deploy these next-generation security features early. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721286409/en/ As generative and agentic AI mature to drive rapid, automated cyberattacks, traditional multi-factor authentication (MFA
Gurobi Publishes Inaugural State of Mathematical Optimization in Academia Report21.7.2026 15:00:00 CEST | Press release
Findings showcase how academics are leveraging optimization alongside GenAI tools in the classroom and in research today. Gurobi Optimization, LLC, the leader in decision intelligence technology, today announced the publication of its inaugural State of Mathematical Optimization in Academia Report. Based on surveys of over 1,180 faculty and students who actively use Gurobi, the report examines how optimization is being taught, used in research, and applied across academia today—as well as use cases that could benefit from a combination of generative AI (GenAI) with optimization. Gurobi’s research highlights the importance of making optimization education and tools accessible to students and instructors. “Mathematical optimization is powering some of the most effective decision-making across today’s enterprises, and the academic community is key to advancing its theory and practice,” said Duke Perrucci, CEO, Gurobi. “By exploring how students, researchers, and educators are teaching and
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