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
Operio Group Named Distributor for Schaefer Technologies in the United Kingdom and European Union9.3.2026 22:00:00 CET | Press release
Operio Group has signed a distribution agreement with Schaefer Technologies, a manufacturer of semi-automatic encapsulation equipment. Operio Group, a holding company building a global group of brands serving the solid dose manufacturing industry, will be the official distributor of Schaefer Technologies’ products in the United Kingdom and the European Union. Schaefer Technologies develops semi-automatic capsule filling systems, including equipment that produces banded capsules for liquid and pellet formulations used by nutraceutical and pharmaceutical manufacturers. Leadership from both companies worked together to establish the agreement, including Kevin Schaefer, CEO of Schaefer Technologies Inc., and Alastair Sanderson, Chief Business Development Officer at Operio Group. “Schaefer Technologies is looking forward to our new relationship with Operio Group,” said Schaefer. “Their understanding of the pharmaceutical equipment market makes them a strong partner as we combine our experti
Kinaxis Goes All-In on Innovation at Upcoming Kinexions in Las Vegas9.3.2026 19:00:00 CET | Press release
Annual customer conference will bring together global supply chain leaders to explore the latest trends, best practices and technologies in AI-powered planning, decision-making and agentic innovation Registration is officially open for Kinexions North America, the premier global supply chain orchestration conference hosted by Kinaxis® Inc. (TSX: KXS). Taking place June 1–3 in Las Vegas, Nevada, the event brings together supply chain leaders, innovators and practitioners from around the world to explore how organizations can leverage AI-driven strategies and technologies to connect data, people and decisions. After a year defined by market volatility, geopolitical risk and disruption, this year’s conference will focus on how intelligent supply chain orchestration enables organizations to move beyond reactive planning to building true enterprise adaptability. The program promises to be the most immersive and future-forward Kinexions yet, with renowned author, entrepreneur and innovation
InterSystems Appoints Former NHS and Mass General Leader Dr. Tim Ferris as Vice President, Healthcare Practice9.3.2026 17:00:00 CET | Press release
InterSystems, a creative data technology provider powering more than one billion health records globally, today announced the appointment of Tim Ferris, M.D., as Vice President, Healthcare Practice. The announcement comes as healthcare leaders gather for the 2026 HIMSS Global Health Conference & Exhibition. In this role, Dr. Ferris will leverage his comprehensive view of the industry to help drive the clinical and strategic direction of the company’s healthcare solutions worldwide. Drawing on his vast experience, he will serve as a strategic advisor to global health systems and governments, engineer targeted technology solutions based on real-world executive needs, advance his academic research on health data architecture and lead public discourse on the intersection of AI and care delivery. Dr. Ferris brings a unique global perspective to InterSystems that is virtually unmatched in healthcare. His career spans 30 years as a practicing primary care physician, executive leadership at pr
Radial Selects Riskified to Power Payment Fraud and Refund/Return Protection for Merchant Client Portfolio9.3.2026 15:00:00 CET | Press release
The partnership brings Riskified’s AI-powered platform for payment fraud, refund claim, and return abuse protection to Radial’s global network of merchants Riskified (NYSE: RSKD), a leader in ecommerce fraud and risk intelligence, today announced a strategic partnership with Radial, a leading 3PL set to become Paxon later this year. Radial will integrate with Riskified’s AI-powered platform to help its merchants approve more legitimate orders and reduce losses from payment fraud, including many merchants that use Shopify as their ecommerce platform. Radial supports many of the world’s most recognized retail brands with a global ecommerce fulfillment network of more than 20 centers across North America, helping merchants deliver orders quickly and cost effectively. By bringing Riskified’s AI-powered fraud decisioning into its commerce ecosystem, Radial gives merchants the surgical ability to calibrate the checkout experience according to risk—without slowing fulfillment. This also suppo
Boomi Activates Data for the Enterprise9.3.2026 14:00:00 CET | Press release
New platform innovations activate contextual data to power production-scale enterprise AI, with a new European platform instance for localized control Boomi™, the data activation company, today announced new capabilities within the Boomi Enterprise Platform. Data activation brings data to life across systems and processes, delivering it with the right context and timing to power everything from AI to BI. The Boomi Enterprise Platform, the foundation that puts data in motion, now adds new semantic context to help AI agents operate on grounded business realities, expands governed SAP data movement with change data capture, enhances transparency and oversight across agentic workflows, and introduces a dedicated European platform instance for localized data control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260309682526/en/ Boomi Activates Data for the Enterprise “Last year, Boomi helped enterprises move from experimentatio
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