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Remdesivir Granted FDA Orphan Drug Status For Potential Treatment Of COVID-19

Mar 24, 2020

The U.S. FDA granted an orphan drug designation to Gilead Sciences' Remdesivir, as a potential treatment for COVID-19, on Mar 23rd, 2020.

About Remdesivir

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity – it is not approved anywhere globally for any use. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19. The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19.--From GILEAD

About Orphan Drug Designations

Orphan status is reserved for drugs that treat conditions that are thought to have limited potential for profitability without government sponsorship or assistance. Companies that sponsor a drug eligible for orphan status gain access to incentives designed to aid development, such as tax credits for clinical testing and a seven-year exclusivity window on production.--From FOXBusiness