Relief Therapeutics and NeuroRx Seek EUA for COVID-19 Treatment

Relief Therapeutics and NeuroRx have applied to the FDA for an Emergency Use Authorization (EUA) for RLF-100 (aviptadil) for the treatment of critical COVID-19 patients with respiratory failure.

The emergency use request targets the same critically ill population that the FDA allowed to receive the drug under an expanded access protocol.

Aviptadil is currently being investigated in two phase 2/3 clinical trials in the U.S. for respiratory deficiency due to COVID-19. It is a synthetic form of a natural peptide that blocks replication of the SARS-CoV-2 coronavirus in human lung cells and immune cells. The agency previously granted aviptadil an Orphan Drug designation for the treatment of acute respiratory distress syndrome.

Last month, the company reported that aviptadil led to rapid recovery of COVID-19 patients with respiratory failure who were given access to the drug under the FDA’s investigational new drug (IND) program (DID, Aug. 4). Since then, the agency has granted another IND allowing the company to test an inhaled formulation of the drug to prevent progression to respiratory failure in moderate and severe COVID-19 patients. — Jordan Williams