RIDGEFIELD, Conn., May 2, 2023 /PRNewswire/ -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for spesolimab as an investigational treatment for the prevention of flares in adults with generalized pustular psoriasis (GPP).
GPP is a rare and potentially life-threatening chronic neutrophilic skin disease characterized by flares of widespread eruptions of painful, sterile pustules across the body. Flares greatly affect a person's quality of life and can lead to hospitalization with serious complications, including heart failure, renal failure, sepsis, and death.
"GPP flares can appear suddenly and intensify quickly, often leaving patients with a heavy emotional burden," said Claudia Beqaj, Executive Director, Dermatology, Sales and Marketing, Boehringer Ingelheim. "The FDA's action reinforces the potential of spesolimab and represents a critical step in bringing this treatment to patients who need it most. We look forward to working with the FDA to accelerate the development of this treatment."
The FDA's Breakthrough Therapy designation is intended to expedite the development and review of a medicine that is intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available treatments.
Spesolimab is marketed as SPEVIGO (spesolimab-sbzo) injection, for intravenous use by Boehringer Ingelheim
Pharmaceuticals, Inc. (BIPI) and is indicated for the treatment of GPP flares in adults. Spesolimab is being investigated for use in additional GPP settings. The safety and efficacy of spesolimab in these settings has not been established. SPEVIGO (spesolimab-sbzo) injection, for intravenous use is not approved for any additional uses in adults or pediatric patients.
Important Safety Information
Do not receive SPEVIGO if you have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the ingredients in SPEVIGO.
What is the most important information I should know about SPEVIGO?
SPEVIGO may cause serious side effects, including:
Before you receive SPEVIGO, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the most common side effects of SPEVIGO:
These are not all of the possible side effects of SPEVIGO. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see Prescribing Information and Medication Guide.
About generalized pustular psoriasis (GPP)
GPP is a rare, heterogenous and potentially life-threatening chronic neutrophilic skin disease, which is clinically distinct from plaque psoriasis. GPP is caused by neutrophils (a type of white blood cell) accumulating in the skin, resulting in painful, sterile pustules all over the body. The clinical course varies, with some patients having a relapsing disease with recurrent flares, and others having a persistent disease with intermittent flares. While the severity of GPP flares can vary, if left untreated they can be life-threatening due to complications such as sepsis and multisystem organ failure. This chronic, systemic disease has a substantial quality of life impact for patients and increased healthcare burden. GPP has a varied prevalence across different geographical regions and more women are affected than men.
GPP flares can lead to hospitalization with serious complications, including heart failure, renal failure and sepsis, and the unpredictability and severity of these flares greatly affect a person's quality of life.
Boehringer Ingelheim Immunology: Pioneering Science, Inspired By Patients
Living with fibrotic and inflammatory diseases greatly impacts patients' lives emotionally and physically. These patients are our guides, partners, and inspiration as we redefine treatment paradigms. As a family-owned company, we can plan long-term. Our goal is to discover and develop first-of-their-kind therapies. With a deep understanding of molecular pathways, we are pioneering scientific breakthroughs that target, repair, and prevent many fibrotic and inflammatory diseases. By building on long-term external collaborations, we strive to bring treatment breakthroughs to patients in the shortest time. We won't rest until we can give people the chance to live the lives they want.
Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at www.boehringer-ingelheim.com
Media Contact
Taylor Pepe
Boehringer Ingelheim Pharmaceuticals, Inc.
Phone: +1 518 466 3621
Email: [email protected]
SOURCE Boehringer Ingelheim
These press releases may also interest you
|