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.
