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
Mevion Introduces the First Proton Therapy System Designed for a LINAC Vault at ESTRO 202611.5.2026 08:00:00 CEST | Press release
The MEVION S250-FIT™ creates a new pathway for European cancer centers to integrate proton therapy into existing radiotherapy programs Proton therapy is entering the LINAC vault. At ESTRO 2026, Mevion Medical Systems will introduce the MEVION S250-FIT Proton Therapy System to the European radiation oncology community, the first proton therapy system designed for installation in a standard radiation therapy vault. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507172087/en/ The MEVION S250-FIT™ Proton Therapy System Now both U.S. FDA-cleared and CE-marked under Regulation (EU) 2017/745, the S250-FIT creates a new pathway for cancer centers to bring proton therapy into existing LINAC-based treatment environments, aligning advanced proton capability with the infrastructure, workflows, and capital planning of modern radiation oncology. Stanford Medicine: First S250-FIT Installation On April 7, 2026, Stanford Medicine unveiled
Vedanta FY26 Profit Soars by 22% to $2.8 bn; Enters Demerger Phase11.5.2026 02:30:00 CEST | Press release
India-based Vedanta Limited (BSE: 500295 & NSE: VEDL), a global leader in metals, oil & gas, critical minerals, power and technology, announced its results for the fourth quarter and full year ended 31 March 2026. It has delivered its best-ever financial performance, driven by structurally strong businesses and disciplined execution. For the full year, Vedanta’s Profit stood at an all-time high of $2.8 bn, reflecting a 22% YoY increase and a profit of $1 bn in Q4 FY26, up nearly 90% YoY. Vedanta reported its highest-ever annual revenue of about $20 bn, up 15% YoY, with Q4 revenue at $5.6 bn, an increase of nearly 30% YoY. The Company maintained strong cost leadership, contributing to record EBITDA of $6.3 bn for FY26, up by about 30% YoY, with margins expanding to around 40%. Q4 EBITDA stood at $2.0 bn, up by nearly 60% YoY, with a margin of approximately 44%. The balance sheet strengthened further, with Net Debt/EBITDA improving to 0.95x, supported by strong cash generation. Underscor
Andersen Global udvider sin afrikanske platform med tilføjelsen af medlemsfirma i Namibia9.5.2026 02:35:00 CEST | Pressemeddelelse
Andersen Global udbygger sin tilstedeværelse i Afrika med tilføjelsen af Andersen in Namibia, da Windhoek Advisory & Taxation tager Andersen-brandet til sig og styrker sine forudsætninger for at betjene virksomheder med aktiviteter i et af det sydlige Afrikas dynamiske vækstmarkeder. Andersen in Namibia har været et samarbejdsfirma siden 2021 og er en lokalt ejet revisions- og konsulentvirksomhed, der leverer ydelser inden for regnskab, skat og forretningsrådgivning, tilpasset de unikke behov i Namibias erhvervsklima. Med ekspertise inden for minedrift, landbrug, logistik, turisme og finansielle tjenesteydelser – sektorer, der er afgørende for Namibias økonomi – bistår firmaet både indenlandske virksomheder og internationale selskaber, der etablerer sig i regionen. Gennem cloudbaseret teknologi og datadrevet indsigt leverer Andersen i Namibia effektive og skalerbare løsninger, der gør det muligt for virksomheder at optimere deres drift, håndtere skatteforpligtelser på tværs af jurisdik
Andersen Consulting styrker sine kompetencer inden for organisatorisk transformation med Afiniti8.5.2026 20:45:00 CEST | Pressemeddelelse
Andersen Consulting annoncerer en samarbejdsaftale med Afiniti, et globalt konsulentfirma inden for forretningstransformation med hovedkontor i Storbritannien, der hjælper organisationer med at levere og opretholde komplekse forandringsprojekter. Afiniti blev stiftet i 2003 og er et globalt konsulenthus inden for forretningsforandring med base i Storbritannien og USA. De støtter klienter gennem komplekse transformationer på tværs af mennesker, processer, systemer og data, og de skaber mærkbare forandringer gennem kreative konsulentydelser. Virksomheden betjener primært stærkt regulerede, sikkerhedsdrevne og aktivtunge organisationer med store, geografisk spredte arbejdsstyrker inden for sektorer som energi, forsyning, biovidenskab, transport og byggeri. Afiniti samarbejder med velkendte brands om at levere ekspertise fra start til slut på tværs af organisatoriske, digitale og ai-baserede transformationer samt ændringer i kultur og driftsmodeller. Dette gælder især komplekse scenarier s
Verdantis Launches MRO360 “The World's First AI-Native Spare Parts Intelligence Platform”8.5.2026 15:40:00 CEST | Press release
MRO360 is the first milestone in Verdantis's journey to deliver the industry's first fully AI-native Enterprise Asset Management solution. Verdantis today announced the global launch of MRO360, a purpose-built AI platform that transforms how asset-intensive organizations manage their MRO spare parts inventory. Designed for manufacturers, oil and gas operators, mining companies, utilities, and other industrial enterprises, MRO360 deploys nine interconnected AI agents that continuously forecast demand, score parts criticality, manage obsolescence risk, calculate dynamic reorder points, helps intercompany plant transfer thereby realizing the exact dollar value of every optimization opportunity across a spare parts catalog in real time. Unlike traditional EAM and CMMS platforms built on static rules, MRO360's agents adapt continuously as demand patterns, supplier performance, and equipment health evolve. For the first time, a maintenance planner can see which work orders are at supply risk
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