CDSCO Approves Antibody For Rare Skin Disorder In Indian Adults

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.

Related Posts

  • Pharma
  • February 10, 2025
  • 92 views
DGFT Amends Standard Input Output Norms For Erythromycin Stearate Tablets

Mumbai:  The Directorate General of Foreign Trade (DGFT), under the ministry of commerce & industry, has announced amendments to the Standard Input Output Norms (SION) for the export of erythromycin…

  • Pharma
  • February 10, 2025
  • 96 views
CSIR-NIIST Develops Technology To Convert Biomedical Waste Into Soil Additives

THIRUVANANTHAPURAM: CSIR-National Institute for Interdisciplinary Science and Technology (NIIST) in Thiruvananthapuram has developed a technology that converts pathogenic biomedical waste into value-added soil additives that eliminate the need for costly…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

An Index To Gauge States For Drug Enforcement, Improve Drug Quality

An Index To Gauge States For Drug Enforcement, Improve Drug Quality

DGFT Amends Standard Input Output Norms For Erythromycin Stearate Tablets

DGFT Amends Standard Input Output Norms For Erythromycin Stearate Tablets

CSIR-NIIST Develops Technology To Convert Biomedical Waste Into Soil Additives

CSIR-NIIST Develops Technology To Convert Biomedical Waste Into Soil Additives

As Always Ahead of Game in healthcare, Doc was first to vote too

As Always Ahead of Game in healthcare, Doc was first to vote too

Pharma stock jumps after it launches Kojiglo serum in India for facial hyperpigmentation

Pharma stock jumps after it launches Kojiglo serum in India for facial hyperpigmentation

Uniform Code Of Pharmaceuticals Marketing Practices 2024 Outlines Guidelines Regarding Promotion Of Drugs Among Doctors: Minister

Uniform Code Of Pharmaceuticals Marketing Practices 2024 Outlines Guidelines Regarding Promotion Of Drugs Among Doctors: Minister