Home CompaniesBoehringer Ingelheim Boehringer’s Spevigo (spesolimab) Bags First FDA Approval for Rare Skin Disease, for Generalized Pustular Psoriasis (GPP)

Boehringer’s Spevigo (spesolimab) Bags First FDA Approval for Rare Skin Disease, for Generalized Pustular Psoriasis (GPP)

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Boehringer Ingelheim


  • German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised pustular psoriasis (GPP), in the US.
  • The FDA has cleared the IL-36 receptor inhibitor under the Spevigo brand name to treat the devastating eruptions of painful blisters, known as flares, that are a characteristic of GPP.
  • The flares can be serious enough to hospitalise patients with complications like heart failure, renal failure and sepsis.
Boehringer Ingelheim

Boehringer Ingelheim : Value Through Innovation.

The world’s largest privately owned pharma Became the first company to score an FDA approval to treat generalized pustular psoriasis (GPP), a rare and life-threatening skin condition that causes eruptions of painful blisters. These GPP flares are so disruptive to the system that they can trigger heart failure, renal failure or sepsis.

The nod is for BI’s antibody drug Spevigo. The IL-36 receptor inhibitor is also under review in Europe, and a decision is expected before the end of this year. It is the first dermatology approval for the German firm.

About Spevigo (spesolimab)

  • API-spesolimab
  • Description-Spesolimab is a novel, humanized, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogeneses of several autoimmune diseases, including GPP. Spesolimab is also under investigation for the prevention of GPP flares and for the treatment of other neutrophilic skin diseases, such as palmoplantar pustulosis (PPP) and hidradenitis suppurativa (HS).
  • Class –Anti-inflammatories; Antipsoriatics; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action –Interleukin 36 receptor antagonists
  • Orphan Drug Status-Yes – Generalised pustular psoriasis
  • IndicationGeneralised pustular psoriasis
  • Biologic Classification -Protein Based Therapies, Monoclonal antibody (mAb)

Spevigo also led to clear or almost clear skin in 43% of treated patients, whereas only 11% of placebo comparators reached such an endpoint.

EFFISAYIL 1 enrolled 53 patients, most of whom had high or very high pustule density and low quality of life at the start of the trial. Spevigo was given at 900-mg intravenous doses. The drug’s effect remained durable throughout the duration of EFFISAYIL and led to a better quality of life.

Afflicting one out of every 10,000 people, GPP is a rare and heterogeneous disease that can become life-threatening if left unchecked. It develops when neutrophils accumulate in the skin, which gives rise to painful pustules over the body. In some patients, GPP relapses with recurrent flares, while others experience persistent GPP with intermittent flares. Severe complications of GPP include sepsis and multi-organ failure.

Spevigo is an intravenous humanized selective antibody and treats GPP by blocking the interleukin-36 receptor, which has been shown to play an important role in many auto-inflammatory conditions. According to the company spokesperson, Spevigo is also being investigated as a way to prevent GPP flares. Studies of the drug are also underway in other neutrophilic skin conditions.

Spevigo has been awarded the Breakthrough Therapy, Priority Review, Orphan Drug and Rare Disease designations in various jurisdictions, including the U.S., China, Taiwan, Korea and Australia. In October 2021, the European Medicines Agency also validated the marketing authorization application for Spevigo. Regulatory review of the drug is ongoing in other countries.

About generalized pustular psoriasis (GPP)
GPP is a rare, heterogenous and potentially life-threatening 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 healthcare burden. GPP has a varied prevalence across different geographical regions and more women are affected than men.

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.

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