BOEHRINGER-INGELHEIM
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
Andersen Global udvider sine skattekompetencer i Afrika med tilføjelsen af Luca Pacioli8.1.2026 21:02:00 CET | Pressemeddelelse
Andersen Global udvider sin tilstedeværelse i Nordafrika gennem en samarbejdsaftale med Luca Pacioli, et skatte-, regnskabs- og selskabsservicefirma med hovedsæde i Tunesien og kontorer i Tunis og Sfax. Luca Pacioli blev stiftet i 1986 af Mongi Ben Mahmoud og ledes nu af administrerende partner Arcelin Ben Mahmoud. Virksomheden er registreret hos den tunesiske revisorforening (OECT) og leverer integrerede skatte-, regnskabs- og virksomhedsrådgivningstjenester baseret på dyb teknisk ekspertise og indsigt i lovgivningen. Firmaet tilbyder fuld support inden for skatterådgivning og -planlægning, international beskatning og IBFD-certificeret transfer pricing samt skattesager og retssager, compliance- og HR-tjenester, finansiel rapportering og M&A-rådgivning. Dets omfattende kompetencer strækker sig også til stiftelse, administration og omstrukturering af selskaber og juridiske sekretariatsydelser, hvilket gør det muligt for lokale og internationale kunder på tværs af sektorer som finans, pr
SPIE, the International Society for Optics and Photonics, Announces Its 2026 Society Awards8.1.2026 18:26:00 CET | Press release
The 22 award recipients represent an exciting range of stellar achievements across light-based sciences and technologies Today, the Awards Committee of SPIE, the international society for optics and photonics, announced the recipients of its prestigious annual awards. Honoring transformative advancements across a range of professional areas — including medicine, astronomy, lithography, optical metrology, optical design, and community leadership — the Society's awards recognize technical accomplishments as well as committed service to SPIE and support of its organizational mission. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108227351/en/ SPIE, the international society for optics and photonics, awarded their Gold Medal to Maryellen Giger (pictured here with her team) for pioneering work in computer-aided diagnosis and image analysis/AI, significant impact on clinical translation, and supporting the next generation of m
PUMA Appoints Nadia Kokni as Vice President Global Brand Marketing8.1.2026 16:30:00 CET | Press release
Sports company PUMA has appointed Nadia Kokni as Vice President, Global Brand Marketing, effective January 1, 2026. Nadia joins PUMA’s global leadership team and reports directly to Chief Brand Officer Maria Valdes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108099913/en/ Sports company PUMA has appointed Nadia Kokni as Vice President, Global Brand Marketing, effective January 1, 2026. Nadia joins PUMA’s global leadership team and reports directly to Chief Brand Officer Maria Valdes. In her new role as PUMA’s most senior global marketing leader, Nadia will oversee brand marketing strategy, brand marketing creative direction, integrated marketing and communication globally. Her appointment comes as PUMA accelerates its global brand ambition and sharpens storytelling around its product icons and innovation pipeline. Nadia brings deep international experience shaping and transforming leading global brands across the spor
Golub Capital Continues Strong Track Record of Consistent Results in 20258.1.2026 16:00:00 CET | Press release
Another Year of “Good Boring” through SpecializationClosed $25+ Billion in Financing Commitments in 2025Raised a Firm Record $20.5 Billion of New Investment CapitalLaunched GP-Led Secondaries Strategy Golub Capital delivered another year of “good boring,” consistent results for its stakeholders in 2025, aided by its commitment to specialization. “We have long believed that specialization is a key source of competitive advantage for Golub Capital,” said David Golub, President of the Firm. “The past year validated this. Our deep relationships, scale and expertise enabled us to continue delivering strong results for investors, sponsors, portfolio companies and our team despite a muted M&A environment and high levels of credit stress across the private equity ecosystem. We are grateful for our clients’ trust and remain committed to building long-term, win-win partnerships that endure through market cycles.” 2025 Highlights, based on preliminary results:1 Delivering strong credit performanc
Xsolla Kicks Off Two Weeks of Industry Programming, Community Events, and Expanding Support for Global Developers Across the UK at the Industry’s Biggest Winter Event8.1.2026 16:00:00 CET | Press release
Coordinated Activations in the UK Underscore Xsolla’s Ongoing Commitment to Building All The Things for the Video Community in Europe Xsolla, a global video game commerce company that helps developers launch, grow, and monetize their games, today announces a comprehensive program of events and activations across the United Kingdom taking place from January 10 to 22, 2026. This coordinated programming schedule reflects Xsolla’s continued investment in the UK and European games ecosystem. Capitalizing on a pivotal moment in the global games calendar, Xsolla is bringing developers, partners, and creators together through partnerships, live events, thought leadership, and community building. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108943976/en/ (Graphic: Xsolla) “Pocket Gamer Connects London brings together one of the most diverse and forward-thinking communities in the mobile global games industry,” said Berkley Egene
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