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
Pimicotinib Approved as Systemic Treatment in China for Tenosynovial Giant Cell Tumor22.12.2025 09:00:00 CET | Press release
First regulatory approval in the world for pimicotinib based on positive data from global Phase 3 MANEUVER studyIn MANEUVER, pimicotinib significantly improved objective response rate at week 25 (54% vs. 3.2% for placebo), while providing clinically meaningful and statistically significant improvements across all patient-reported outcomesWith longer-term follow-up, 3 out of 4 patients treated with pimicotinib achieved response per RECIST v1.1, and treatment continued to be well-toleratedApproval strengthens Merck’s leadership in rare tumors, with additional ongoing regulatory filings for pimicotinib underway globally Merck, a leading science and technology company, announced today that following Priority Review, the China National Medical Products Administration (NMPA) has approved pimicotinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause functional limitation or relatively severe morbidity.
Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Rituximab and Lenalidomide for the Treatment of Relapsed or Refractory Follicular Lymphoma22.12.2025 08:44:00 CET | Press release
Incyte Biosciences Japan G.K. today announced approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). “Today's approval of Minjuvi in combination with rituximab and lenalidomide marks a significant milestone as the first dual-targeted CD19 and CD20 immunotherapy combination for relapsed or refractory FL in Japan,” said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan. “By improving progression-free survival, Minjuvi offers a chemotherapy-free option for eligible patients with relapsed or refractory disease. This approval underscores our commitment to bridging critical treatment gaps to patients and families affected by this challenging disease in Japan.” The approval is based on the pivotal Phase 3 inMIND trial, which enrolled 654 adult patients, including patients based in Japan. The study demonstrated that Minjuvi
Incyte Japan Announces Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Anal Cancer22.12.2025 08:42:00 CET | Press release
Incyte Biosciences Japan G.K. today announced the Japan Ministry of Health, Labour and Welfare (MHLW) approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC). "Today's approval marks a significant milestone for patients with advanced anal cancer in Japan – the MHLW’s approval of Zynyz as the first and only first-line treatment for SCAC," said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan G.K. "By offering combination therapy with chemotherapy, Zynyz provides a vital new path forward for patients facing this challenging disease, addressing a significant unmet need in cancer care for patients with SCAC and their families." The approval was based on data from the Phase 3 POD1UM-303/InterAACT2 trial evaluating Zynyz in combination with platinum-based chemotherapy (carboplatin-paclitaxel) in adult patients with metastatic or inoperable
GBC AG Analyst Coverage Report on Mexedia S.p.A. Società Benefit Completed and Published22.12.2025 08:30:00 CET | Press release
Regulatory News: Mexedia S.p.A. Società Benefit (Euronext Growth Paris: ALMEX, ISIN IT0005450819) (“Mexedia” or the “Company”) informs that the analyst coverage report prepared by GBC AG – one of the leading independent financial research firms in Germany –, developed within an issuer-sponsored research framework, has been completed and is now publicly available. The report follows the re-initiation of analyst coverage by GBC AG previously communicated by the Company and is based exclusively on publicly available information. The content, assumptions and conclusions of the report are solely attributable to the analyst. The GBC AG analyst coverage report is available on the Company’s official website at the following address: https://mexedia.com/en/financial-statements-and-reports/ and on the analyst’s website. Daniel Gilcher, Chief Financial Officer of Mexedia S.p.A. Società Benefit, stated: “The completion and publication of the analyst coverage report by GBC AG represents the conclus
Hisense Joins HEVC Advance Patent Pool22.12.2025 03:06:00 CET | Press release
Access Advance LLC, the global leader in video codec patent pool licensing, today announced that Hisense Group Holdings Co., Ltd. has joined the HEVC Advance Patent Pool as a Licensee. Hisense joins the recent additions to the Access Advance patent pools, including Xiaomi, MSI, Transsion, and expanded relationships with Huawei, HP and Sharp. Hisense, headquartered in Qingdao, China, is one of the world's largest television manufacturers, with a global presence spanning Asia, Europe, the Americas, and beyond. The company's products reach consumers in more than 160 countries and regions worldwide. "We are pleased to welcome Hisense to the HEVC Advance Patent Pool," said Peter Moller, CEO of Access Advance. "This agreement is the result of extensive engagement between our teams over a considerable period of time. Hisense's decision to join the pool reflects a recognition that transparent, efficient licensing solutions benefit both innovators and implementers across the video technology ec
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