Industry News

5/2/2023 – U.S. FDA Grants Breakthrough Therapy Designation for Spesolimab for the Prevention of Flares in Adults with Generalized Pustular Psoriasis (GPP)

  • Breakthrough Therapy designation is supported by results from the Effisayil™ 2 trial which studied spesolimab in the prevention of flares in adults with generalized pustular psoriasis (GPP)
  • GPP is an unpredictable systemic skin disease where flares present as painful, sterile pustules that profoundly impact physical and mental health

Ridgefield, Conn., May 2, 2023 – 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:

  • Infections. SPEVIGO may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SPEVIGO and may treat you for TB before you begin treatment with SPEVIGO if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB after treatment with SPEVIGO. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
    • fever, chills or sweats
    • muscle aches
    • cough
    • shortness of breath
    • blood in your phlegm (mucus)
    • burning when you urinate
    • urinating more often than normal
  • Allergic reactions and infusion-related reactions. Serious allergic reactions may happen during or after your infusion of SPEVIGO. If you have a serious allergic reaction, your healthcare provider will stop treatment with SPEVIGO. If you have an infusion-related reaction, your healthcare provider will stop your SPEVIGO infusion and treat your symptoms and may restart SPEVIGO at a slower infusion rate. Tell your healthcare provider or get emergency medical help right away if you get any of the following symptoms during or after your infusion of SPEVIGO:
    • feeling faint, dizzy, or lightheaded
    • swelling of your face, eyelids, lips, mouth, tongue, or throat
    • trouble breathing or throat tightness
    • fever
    • mouth sores
    • chest tightness
    • hives or skin rash that is different than the rash from generalized pustular psoriasis (GPP)
    • itching
    • swollen lymph nodes

Before you receive SPEVIGO, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection that does not go away or that keeps coming back.
  • have TB or have been in close contact with someone with TB.
  • have recently received or are scheduled to receive an immunization (vaccine). You should not receive live vaccines after treatment with SPEVIGO.
  • are pregnant or plan to become pregnant. It is not known if SPEVIGO can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SPEVIGO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with SPEVIGO.

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:

  • feeling tired or weak
  • nausea and vomiting
  • headache
  • itching or itchy bumps
  • a collection of blood under the skin at the infusion site or bruising
  • urinary tract infection

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 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.

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