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
Latifa bint Mohammed Inaugurates ISEA20269.11.2026 14:30:00 CET | Press release
Her Highness Sheikha Latifa bint Mohammed bin Rashid Al Maktoum, Chairperson of Dubai Culture and Arts Authority, inaugurated the 31st International Symposium on Electronic/Emerging Art (ISEA2026 Dubai), held under the theme ‘ELYAH: Constellating Place, Data, and Identity.’ Bringing together artists, researchers and innovators from around the world, the symposium, in its largest-ever edition, explores how art, science and technology can expand creative expression, deepen cultural understanding, and shape the future of electronic and emerging art. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261109319593/en/ Burj Khalifa lights up to celebrate the opening of ISEA2026 Dubai (Photo: AETOSWire) Her Highness marked the inauguration by launching the interactive ELYAH show at ARTE MUSEUM Dubai. Inspired by Dubai’s celestial heritage, the experience combined light, music, performance and digital technology to explore the relations
Muslim World League’s “Minhaj” App Participates in Hajj Conference and Exhibition 2026 in Jeddah9.11.2026 14:04:00 CET | Press release
The “Minhaj” app, developed by the Muslim World League (MWL), is participating in the sixth edition of the Hajj Conference and Exhibition 2026, which commenced today in Jeddah under the patronage of the Custodian of the Two Holy Mosques, King Salman bin Abdulaziz Al Saud (may Allah protect him). Organized by the Ministry of Hajj and Umrah in cooperation with the Pilgrim Experience Program, one of the programs of Saudi Vision 2030, the event is being held from November 8 to 11 at the Jeddah Superdome under the theme “From Makkah to the World.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261109411972/en/ The pavilion of the Muslim World League (MWL) at the sixth edition of the Hajj Conference and Exhibition 2026 in Jeddah, Saudi Arabia. (Photo: AETOSWire) Minhaj’s participation in this international event aims to introduce its integrated Islamic digital ecosystem, launched from Makkah to serve Muslims worldwide. The app off
CAIRDAC Adds Operational Expertise to Its Board of Directors With the Appointment of Rinda Sama9.11.2026 13:44:00 CET | Press release
CAIRDAC, SA, a pre-revenue-stage medtech company developing ALPS™, a leadless, self-powered cardiac pacing system, today announced the appointment of Mr. Rinda Sama to its Board of Directors. His appointment adds deep manufacturing, quality and operational experience to the Board and follows the recent appointment of Raymond W. Cohen as Chairman. “Mr. Sama’s extensive experience in manufacturing, quality systems and operational scale-up for complex implantable devices will be extremely valuable to our Company as we prepare for clinical evaluation and the next stages of development,” said Edouard Fonck, Chief Executive Officer of CAIRDAC. Mr. Sama currently serves as CEO of Spiro Medical, a company focused on treating asthma employing a proprietary neuromodulation system. He previously served as Chief Operating Officer of publicly traded Axonics, Inc. where he was accountable for manufacturing and quality and the operational infrastructure that supported the company’s commercial growth.
Nominations Open for Sixth Edition of Aster Guardians Global Nursing Award 2027 Worth USD 250,000 Prize9.11.2026 13:35:00 CET | Press release
Aster DM Healthcare has announced the launch of the sixth edition of the Aster Guardians Global Nursing Award, inviting registered nurses worldwide to showcase their contributions to healthcare and compete for a prize of USD 250,000. The award recognises nurses whose work advances patient care, strengthens healthcare systems, drives innovation and transforms communities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261109180902/en/ Aster Guardians Global Nursing Award - One nurse will win the trophy and the prize of USD 250,000 (Photo: AETOSWire) Open to registered nurses worldwide, the award recognises contributions across five areas: Patient Care, Nursing Education, Social and Community Service, Research and Innovation, and Nursing Leadership and Administration. Applicants can share their professional journeys through case-study questions, in multiple languages at www.asterguardians.com until December 31, 2026. The 2026
Datavault AI and Biochar Now Combine Insured Carbon Removal Credits with Patented Tokenization Technology9.11.2026 12:45:00 CET | Press release
Datavault AI Inc. (“Datavault” or the “Company”) (Nasdaq: DVLT), today announced a global strategic collaboration with Biochar Now to expand the distribution of verified, insured carbon removal credits through Datavault’s patented tokenization technology and global marketing and distribution capabilities. The partnership is designed to connect Biochar Now’s carbon removal credits with a broader network of buyers while strengthening transparency, traceability and accountability in the carbon markets. Under the agreement, Datavault AI will provide access to its carbon credit tokenization technology, including U.S. Patent No. 12,443,977 and related pending applications. It will also support worldwide demand generation, buyer development, marketing and distribution of eligible Biochar Now carbon credits, while also pursuing listings with existing and future partner exchange platforms. Biochar Now will pay Datavault AI for its technology and services; specific financial terms were not discl
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