Mumbai: The Central Drugs Standard Control Organisation (CSDCO) on Wednesday approved Boehringer Ingelheim’s Spevigo (Spesolimab) injection, a first-in-class treatment for adults suffering from Generalised Pustular Psoriasis (GPP) flares — a rare skin disorder — in India.
GPP is a rare and unpredictable systemic disease, which manifests with painful pus-filled blisters, redness, inflammation, and scaling on the skin, often accompanied by systemic symptoms like fever and fatigue.
Spesolimab works as 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.
In the Phase II global clinical trial, GPP patients (54 per cent) treated with Spesolimab showed no visible pustules after one week, compared to placebo (6 per cent). Most of them at the outset of the trial had a high, or very high, density of pustules, and impaired quality of life, the company said.
In India, GPP presents a significant healthcare challenge, affecting individuals of all ages and demographics. While precise prevalence data for GPP in India is limited, GPP is widely recognised as a rare disease.
“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’,” said Gagandeep Singh Bedi, Managing Director, Boehringer Ingelheim India.
“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,” added Gagandeep.
The CDSCO’s decision follows existing approvals in the European Union, US, China, and Japan, the company said.
