FDA approves Spevigo for the treatment of generalized pustular psoriasis (GPP) in adults

Boehringer Ingelheim announced on Sep 1 that the U.S. Food and Drug Administration (FDA) has approved Spevigo for the treatment of generalized pustular psoriasis (GPP) in adults. it is the first approved treatment option for generalized pustular psoriasis in adults. Spevigo is a new, selective antibody that inhibits the activation of the interleukin-36 receptor (IL-36R), an important 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, MD, principal investigator and publication author, and dean for clinical therapeutics, New York. “The approval of SPEVIGO is a turning point for dermatologists and physicians. We now have an FDA-approved treatment that can help make a difference for our patients, who have no approved option to manage GPP flares.

Different from plaque psoriasis, GPP is a rare and potentially life-threatening neutrophilic skin disease characterized by flares (episodes of widespread eruptions of painful, sterile pustules). In the United States, it is estimated that 1 out of every 10,000 people have GPP. Given that this is very rare, recognizing the signs and symptoms can be challenging and result in a delay in diagnosis.

Karin Broilen, Managing Director, Boehringer Ingelheim’s Responsible for Human Pharma, said: “This significant approval reflects our successful efforts to accelerate our research, aimed at rapidly bringing innovative treatments to those in most need”. “We recognize how devastating this rare skin disease can be for patients, their families, and caregivers. GPP can be life-threatening and to date, there is no specific approved treatment to treat devastating GPP flares. It is a matter of pride for me that with the approval of Spavigo we can now offer the first US-approved treatment option to those in need.

“GPP can have a huge impact on a patient’s physical and emotional well-being. With FDA approval of this new treatment, people living with GPP now hope to learn that there is an option to help treat their flares, said Thomas Seck, MD, medical and regulatory affairs, Boehringer Ingelheim’s senior vice president. “Spevigo represents Boehringer Ingelheim’s commitment to delivering meaningful change for patients with serious diseases with limited treatment options.”