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
  • May 25, 2024
  • 65 views
NPPA Revises Ceiling Price Of Asthma Inhaler Drug Combination In Suo-Moto Correction

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling price of asthma inhaler drug combination formoteral 6 mcg and budesonide 400 mcg dry power inhaler (DPI) under…

  • Pharma
  • May 25, 2024
  • 75 views
Students Will Not Be Able To Take Admission In Pharmacy Institutes With Fake Documents, Strict Monitoring

Jaipur: To provide quality education in pharmacy institutes, the central government has prepared to end the duplicate system. Strict action will be taken against fake students and teachers in newly opened…

Leave a Reply

Your email address will not be published.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

You Missed

A Doctor diagnoses Mood of Voters in Delhi

A Doctor diagnoses Mood of Voters in Delhi

NPPA Revises Ceiling Price Of Asthma Inhaler Drug Combination In Suo-Moto Correction

NPPA Revises Ceiling Price Of Asthma Inhaler Drug Combination In Suo-Moto Correction

Students Will Not Be Able To Take Admission In Pharmacy Institutes With Fake Documents, Strict Monitoring

Students Will Not Be Able To Take Admission In Pharmacy Institutes With Fake Documents, Strict Monitoring

Tripura Police Seized Banned Cough Syrup Worth Rs 30 Lakh In Dhalai; One Arrested

Tripura Police Seized Banned Cough Syrup Worth Rs 30 Lakh In Dhalai; One Arrested

Ex-Pharmacy Council Registrar Gave Certificates To Ineligible Candidates?

Ex-Pharmacy Council Registrar Gave Certificates To Ineligible Candidates?

Experts Call For Ethical Standards, Patient Advocacy In Clinical Research

Experts Call For Ethical Standards, Patient Advocacy In Clinical Research