Business Wire

BOEHRINGER-INGELHEIM

29.10.2021 09:02:12 CEST | Business Wire | Press release

Share
Boehringer Ingelheim announces European Medicines Agency’s filing acceptance and validation of marketing authorization application for spesolimab in generalized pustular psoriasis

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

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Medical University of Graz Enrolls First Patient in DEEPER CHALLENGE Trial Evaluating Spur® Peripheral Retrievable Scaffold System in a Select CLTI Cohort2.7.2026 13:00:00 CEST | Press release

Reflow Medical, Inc. announces that the Medical University of Graz has enrolled the first patient in the DEEPER CHALLENGE clinical trial. This investigator-initiated, single-center, single-arm, prospective study, supported by a grant, investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701995624/en/ The study investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. The study plans to enroll up to 40 patients with chronic limb-threatening ischemia (CLTI) across two distinct cohorts: patients with diabetes and patients with end-stage renal disease receiving hemodialysis for at least six months, with women comprisi

Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)2.7.2026 12:30:00 CEST | Press release

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to eight newly hired non-executive employees. The equity awards were granted on July 1, 2026 and consisted of options to purchase an aggregate of 63,685 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 30,300 shares. The options have an exercise price per share equal to $13.29, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted sh

Infobip Launches PitchMate — An AI Fan Companion for Global Football2.7.2026 12:00:00 CEST | Press release

Two AI agents. Two global sports. One platform redefining what it means to be a fan. Global AI-first cloud communications platform Infobip launched PitchMate, a new AI-powered conversational agent that brings football fans closer to the action of the world’s biggest football tournament. Purpose-built for the global football audience, PitchMate joins the TGR Haas F1 Team RaceMate — Infobip’s AI fan engagement solution for the TGR Haas F1 Team — in demonstrating how conversational AI is transforming fan engagement across sports worldwide. RaceMate, launched last April for this year’s motorsport season, is an AI agent on WhatsApp and Apple Messages for Business that puts TGR Haas F1 Team fans at the center of the action. It delivers real-time race data, personalized content, team radio highlights, trivia, and native multilingual support, turning passive viewers into active participants through natural, human-like conversations across every race weekend. Since its launch, RaceMate has reac

Besins Healthcare Strengthens Innovation Capabilities with Acquisition of UniD Manufacturing, a Specialist in Long-Acting Drug Delivery Technologies2.7.2026 11:00:00 CEST | Press release

Acquisition brings together Besins Healthcare's hormonal health leadership and UniD's expertise in the development and manufacturing of advanced polymer based pharmaceutical formulations.1UniD Manufacturing to become Besins Healthcare PharmTech, serving as a strategic innovation hub within the company while continuing to serve its clients. Besins Healthcare, a global pharmaceutical company specializing in hormonal health, today announced the acquisition of UniD Manufacturing, a Belgium-based pharmaceutical development and manufacturing company with more than 20 years of recognized expertise in long-acting drug delivery technologies.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701779777/en/ Besins Healthcare Strengthens Innovation Capabilities with Acquisition of UniD Manufacturing, a Specialist in Long-Acting Drug Delivery Technologies This acquisition brings together two highly compatible areas. Besins Healthcare bri

ROYC Selected by Slättö as Structuring and Platform Solution for Luxembourg Feeder Fund2.7.2026 10:45:00 CEST | Press release

ROYC, a leading global structuring and platform provider, today announced that Slättö, a Nordic private markets real estate firm, has selected ROYC to establish and manage a Luxembourg-domiciled feeder fund designed to efficiently aggregate individual subscriptions from professional investors. The Luxembourg-domiciled vehicle will be fully structured and administered on ROYC’s proprietary platform, delivering investors a seamless digital experience with real-time portfolio access, automated reporting, and efficient global distribution. ROYC streamlines onboarding and governance, standardizes legal documentation, and broadens access to capital. “Private markets are undergoing a structural shift as global banks and wealth platforms increasingly seek efficient access to high-quality private equity strategies. By combining our deep structuring expertise with ROYC’s digital operating infrastructure, we enable leading managers like Slättö to launch investor-ready vehicles rapidly while deliv

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye