Zuventus first in world to launch aviptadil for ARDS commercially

Discovered in 1970, the drug was tested on severe Covid-19 patients on DCGI's direction

Mumbai-based Zuventus Healthcare has become the first company globally to commercially launch aviptadil, over 50-year old drug molecule, for treating acute respiratory distress syndrome (ARDS).

The drug was discovered by Dr Sami Said, pulmonary medicine specialist, in 1970. Aviptadil -- a complex peptide -- was not commercially used for ARDS, though prescribed as a last resort (orphan drug); it is prepared by Universities for emergency use by hospitals, the company said.

The use of aviptadil (a vasoactive intestinal peptide) restores respiration and reduces mortality in patients with ARDS. “Aviptadil is safe and effective in tackling respiratory failure, shortens recovery time, decreases respiratory distress, and prevents deaths in patients suffering from respiratory failure. However, a commercially stable formulation of aviptadil for such purpose was still out of reach,” Zuventus said.

Company sources told Business Standard that the process of manufacturing aviptadil is extremely complex, and so far none has attempted to manufacture it commercially. “Aviptadil in combination with phentolamine is used to treat erectile dysfunction. However, aviptadil alone has never been commercially made for treating ARDS,” the person said.

Based on its R&D, Zuventus approached the Drugs Controller General of India (DCGI) with such a formulation that was proposed 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 the successful completion of the clinical trial, the product has been approved for the treatment of patients with severe Covid-19 with ARDS… The firm will continue to seek permission for additional use in ARDS in line with permission from the EU and the US,” it said on Friday.

The trial began last year, and took about 9-10 months. Sources indicated that the DCGI reviewed the data multiple times before giving approval. The trial has been conducted on around 150 patients.

Hyderabad-based Dr Reddy’s Laboratories, too, sought DCGI permission to conduct the phase 3 clinical trial on aviptadil. DRL could not be reached for immediate comment.

The USFDA has granted ‘orphan drug’ designation to aviptadil for ARDS and chronic lung diseases. Last year, NeuroRx and Relief Therapeutics announced phase 2/3 clinical trials of this drug on critical Covid-19 patients.

Several drugs were re-purposed during Covid-19, for example, remdesivir, which was originally developed for Ebola.

Leap of Success

• Aviptadil is a 50-year old drug discovered by Dr Sami Said in the US
• Commercially stable formulation of Aviptadil for ARDS was out of reach
• Universities made the drug and supplied to hospitals as the last resort
• Zuventus approached DCGI with a formulation that is commercially stable
• Got approval for clinical trials last year
• DCGI approved aviptadil for treatment of patients with severe Covid-19 with ARDS
• Firm will continue to seek permission for additional use in ARDS