FDA approves Boehringer Ingelheim’s Spevigo
Boehringer Ingelheim has obtained the Food and Drug Administration’s blessing for Spevigo, the first approved treatment option for generalized pustular psoriasis flares in adults.
Spevigo is a novel, selective antibody that blocks the activation of the interleukin-36 receptor, a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP.
“GPP flares can greatly impact a patient’s life and lead to serious, life-threatening complications,” said Mark Lebwohl, lead investigator, publication author and dean of clinical therapeutics at the Icahn School of Medicine at Mount Sinai, Kimberly and Eric J. Waldman department of dermatology in New York. “The approval of Spevigo is a turning point for dermatologists and clinicians. We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares.”
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Distinct from plaque psoriasis, GPP is a rare and potentially life-threatening neutrophilic skin disease, which is characterized by flares (episodes of widespread eruptions of painful, sterile pustules). In the United States, it is estimated that one out of every 10,000 people has GPP. Given that it is so rare, recognizing the signs and symptoms can be challenging and consequently lead to delays in diagnosis, the company said.
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.
“This important approval reflects our successful efforts to accelerate our research with the aim to bring innovative treatments faster to the people most in need,” said Carinne Brouillon, a member of the board of managing directors who is responsible for human pharma at Boehringer Ingelheim. “We recognize how devastating this rare skin disease can be for patients, their families and caregivers. GPP can be life-threatening and, until today, there have been no specific approved therapies for treating the devastating GPP flares. It makes me proud that with the approval of Spevigo we can now offer the first U.S. approved treatment option for those in need.”
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Thomas Seck, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim, said, “GPP can have an enormous impact on patients’ physical and emotional well-being. With the FDA approval of this new treatment, people living with GPP now have hope in knowing that there is an option to help treat their flares. Spevigo represents Boehringer Ingelheim’s commitment to delivering meaningful change for patients living with serious diseases with limited treatment options.”