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
Vertex Receives CHMP Positive Opinion for ALYFTREK®, a New Once-Daily CFTR Modulator for the Treatment of Cystic Fibrosis28.4.2025 08:03:00 CEST | Press release
- ALYFTREK®(deutivacaftor/tezacaftor/vanzacaftor) recommended for people with CF ages 6 years and older with at least one non-class I mutation in the CFTR gene -- In head-to-head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV1 and superior compared to KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) at reducing sweat chloride - Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ALYFTREK®(deutivacaftor/tezacaftor/vanzacaftor)for the treatment of people with cystic fibrosis (CF) ages 6 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. “Our goal has always been to serially innovate to help people with cystic fibrosis live healthier and longer lives. If approved, this new medicine would be indicated for people with CF ages 6 years and older with at least
Prilenia Enters into a Collaboration and License Agreement with Ferrer for the Commercialization and Co-Development of Pridopidine in Europe and Other Select Markets28.4.2025 07:02:00 CEST | Press release
-- Total deal size of approximately €500 million, including approximately €125 million in upfront and near-term milestones ---- Ferrer to commercialize pridopidine in Europe and other select markets; Prilenia retains full commercialization and development rights to pridopidine in North America, Japan and Asia Pacific ---- Co-development agreement in the territory supports further expansion of pridopidine in Huntington’s disease, amyotrophic lateral sclerosis and future indications ---- Pridopidine for Huntington’s disease is currently under review by the European Medicines Agency (EMA) with a CHMP opinion expected in the second half of 2025 -- Prilenia Therapeutics B.V., a biopharmaceutical company driven by an unwavering commitment to scientific excellence and accelerating progress for people affected by Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS), today announced that it has entered into a collaboration and license agreement with Ferrer for the commercialization
Ferrer Enters Into a Collaboration and License Agreement With Prilenia for the Commercialization and Co-Development of Pridopidine28.4.2025 07:00:00 CEST | Press release
Ferrer, an international B Corp pharmaceutical company with an increasing focus on rare neurological diseases, and Prilenia Therapeutics B.V.,a clinical-stage biotech company, have announced the signing of a strategic co-development and license agreement in which Ferrer obtains the rights to develop, manufacture and commercialize Pridopidine in the European Region, the Middle East and North African Region, the Southern African Region, the Central and South American Region, and the Commonwealth of Independent States Region. Pridopidine, a potent and highly selective, orally administered sigma-1 receptor agonist, designed to regulate key neuroprotective mechanisms that are often impaired in neurodegenerative diseases, is a promising candidate for the treatment of Huntington’s Disease (HD), a rare inherited neurodegenerative disease, with a high unmet medical need1. It has been studied in more than 1,700 people and long-term safety data of up to 7 years duration are available from previou
Innorna Announces FDA Rare Pediatric Disease and Orphan Drug Designations Granted to IN013 for Treatment of Wilson Disease27.4.2025 11:36:00 CEST | Press release
Innorna, a clinical-stage biotechnology company revolutionizing mRNA therapeutics with its innovative lipid nanoparticle (LNP) delivery technology, today announced the U.S. Food and Drug Administration (FDA) has granted both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) to its investigational mRNA therapy, IN013, for treating Wilson Disease (WD). This dual achievement accelerates the clinical development of IN013, advancing Innorna’s mission to deliver transformative therapies for WD patients. About FDA Designations The Rare Pediatric Disease Designation (RPDD) incentivizes therapies for serious or life-threatening diseases affecting fewer than 200,000 U.S. patients, primarily those aged 18 or younger. Sponsors may qualify for a Priority Review Voucher (PRV) upon approval to expedite FDA review of a subsequent drug application. The Orphan Drug Designation (ODD) supports therapies targeting rare diseases (affecting fewer than 200,000 U.S. patients) by provi
Everen Specialty Appoints Carla Greaves Chief Underwriting Officer25.4.2025 19:00:00 CEST | Press release
Everen Specialty, a Bermuda-based (re)insurer for energy markets worldwide, today announced the appointment of Carla Greaves as its new Chief Underwriting Officer (CUO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250425273777/en/ Carla Greaves Ms. Greaves will join the Executive Leadership Team of the Everen Group, based in the Bermuda office, later this year. She succeeds Jane Peterson, Interim CUO, who will continue in a consultancy capacity to facilitate the transition. With more than 30 years of underwriting and leadership experience in the (re)insurance industry, Ms. Greaves brings a wealth of expertise and a proven track record of success in the Casualty market where she is recognized for building high-performing teams, driving profitable growth, and successfully navigating complex market environments. Prior to joining Everen Specialty, Ms. Greaves held increasingly senior leadership positions, most recently servin
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