SEC recommends approval for Boehringer Ingelheims spesolimab to treat GPP

New Delhi, February 27, 2023 :

The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended to the drug regulator to grant permission to Boehringer Ingelheim India for import and marketing of Spesolimab formulation for a rare disease of generalised pustular psoriasis (GPP) subject to conditions.

The Committee, which looks into dermatology and allergy related proposals from pharma companies, was approached by Boehringer Ingelheim with a proposal for import and marketing of spesolimab concentrate for solution for infusion 450mg per vial indicated for GPP, with local clinical trial waiver. It also proposed to conduct a global phase IV study including in Indian patients.

The SEC noted that GPP is a rare disease and is potentially life threatening with a pathway of IL-36 in its pathogenesis. It also observed that spesolimab is an IL-36 inhibitor and has received orphan drug designation and breakthrough therapy designation for treatment of the disease in the US.

“At present, there is no similar therapy available in India resulting in an unmet medical need. The drug is currently approved in the US, Japan, EU, China and Taiwan,” it added.

Besides, the company has also proposed to conduct global Phase-IV study including Indian patients which would be open label safety trial to assess the effect of immunogenicity on pharmacokinetics (PK), safety and efficacy on re-treatment of flares that occurs after the first flare incidence has been treated and resolved in GPP flare.

The SEC, after detailed deliberation, recommended for grant of permission to import and market the drug for treatment of flares in adult patients with GPP, subject to the conditions including that the global phase IV study should include reasonable number of patients from India and there should be screening of patients by QuantiFERON-TB Gold test for tuberculosis and positive patients should be excluded from the study.

“Accordingly, the firm is requested to submit a global phase IV clinical trial protocol within three months of import and marketing permission,” added the Committee.

Spesolimab, marketed in the US as Spevigo, is a novel, 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.

GPP is a rare, lifelong skin disease, is characterised by flares which appear suddenly in the form of painful, pus-filled blisters over large areas of the body. It may be accompanied by more general symptoms, such as fever, headache, extreme tiredness, or a burning sensation on the skin. GPP can be confused with the more common plaque psoriasis, but they are distinct diseases.

GPP flares greatly affect a person’s quality of life and can lead to serious and life-threatening complications, including heart failure, renal failure, and sepsis, according to the company.

The company received approval from the US Food and Drug Administration for the use of the drug to treat GPP flares in adults in September, 2022

In the United States, it is estimated that 1 out of every 10,000 people has GPP. Given that it is so rare, recognizing the signs and symptoms can be challenging and consequently lead to delays in diagnosis, said the company while announcing the FDA approval. Pharmabiz