BI gets regulatory approval for novel product to treatgeneralised pustular psoriasis flares

Boehringer Ingelheim said it has received regulatory approval for SPEVIGO (Spesolimab) injection, a novel treatment for generalised pustular psoriasis (GPP) flares in adults.

Spesolimab is a selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signalling pathway within the immune system shown to be involved in the pathogenesis of GPP, a note from the company said.

In India, GPP affects all ages and demographics, though prevalence data was limited, the note said. “GPP is a rare and unpredictable systemic disease, with predominant skin symptoms, that is distinct from plaque psoriasis in both its disease mechanism and severity. Given that it is so rare, recognising the symptoms can be challenging, which leads to delays in diagnosis. It manifests with painful pus-filled blisters, redness, inflammation, and scaling on the skin, often accompanied by systemic symptoms like fever and fatigue.”

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“The approval of SPEVIGO® by the CDSCO (Central Drugs Standard Control Organisation) represents a significant milestone in GPP management in India … We often take our skin for granted. However, for a small percentage of people with a rare, lifelong skin disorder, living in constant anticipation of possible flares that could require emergency medical care is a harsh reality. Some patients often describe the feeling as akin to ‘being on fire’. SPEVIGO’s impact goes beyond treatment; it’s about giving patients the chance to reclaim their lives. It presents a promising opportunity for enhancing effective management, quality of life, and patient outcomes in India, instilling hope for individuals grappling with GPP,” said Gagandeep Singh Bedi, Managing Director, Boehringer Ingelheim India (BII).

Shraddha Bhure, BII Medical Director, added, “GPP is a debilitating condition, with serious symptoms like flares and pustules that can significantly impact patients’ ability to perform daily activities, often leading to significant morbidity and impaired quality of life. SPEVIGO, a targeted therapy, has been shown to effectively reduce the severity of GPP flares, providing patients with an innovative treatment that specifically targets the underlying inflammation associated with GPP, thus providing relief from the distressing symptoms of the disease.”