Acute Respiratory Distress Syndrome (ARDS) came to the centre stage during COVID-19 pandemic as an end stage factor resulting in high mortality. While many interventions were repurposed to improve oxygen saturation, none were commercially available to specifically address the ARDS globally. 

Aviptadil is a complex peptide which was not available commercially for ARDS, though used as last resort (orphan drug) and prepared by Universities for emergency use by hospitals.

The supplementation of Aviptadil, a vasoactive intestinal peptide, restores respiration and reduces mortality in ARDS.  Aviptadil achieves this by protecting and rebuilding Type-2 Pneumocytes, restoring Type-1 Pneumocytes, enhancing surfactant production and inhibiting IL6 & TNF alpha.

However, a commercially stable formulation of Aviptadil for such purpose was still out of reach. Based on its strong R & D, such a formulation was proposed by Mumbai-based Zuventus Healthcare to the Drugs Controller General of India (DCGI) to be allowed for emergency use.  The Subject Expert Committee (SEC) however asked the firm to do a detailed clinical trial in severe COVID-19 patients as an additional intervention.

After successful completion of clinical trial, the product has been approved for “For treatment of patients with severe COVID-19 with Acute Respiratory Distress Syndrome (ARDS).”

The firm will continue to seek permission for additional use in ARDS in line with permission in EU & USA.