Itolizumab: ‘First-In-Class’ Biologic Approved In India For The Emergency Treatment Of ARDS In Patients With COVID-19

The Drug Controller General of India (DGCI) has granted permission to market Itolizumab injection 25 mg/5 mL solution in India for emergency treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS). Itolizumab is the world’s first anti-CD6 novel biologic therapy to be approved for the treatment of patients with moderate-to-severe COVID-19 complications. This approval is based on a multi-centric, randomized, controlled trial.

The study aimed to assess the safety and efficacy of itolizumab in preventing cytokine release syndrome (CRS) and treating acute hyperimmune responses in COVID-19 patients. Cytokine storm is a leading cause of death in COVID-19 patients, and itolizumab’s unique mechanism of action makes it an ideal candidate for treating CRS . Patients who received this drug responded positively and…