Promising COVID-19 Treatment: Gilead Will Not Seek Orphan Drug Status

Gilead Sciences Inc. is investigating the potential of remdesivir, a medicine it has been studying for years as part of its research in antivirals, as a treatment for patients with Covid-19.  On March 23rd, the Food and Drug Administration (FDA) granted Gilead orphan drug status for remdesivir, a designation that gives a manufacturer a seven-year period of market exclusivity for the drug and tax credits on its research and development costs.  After a public outcry, Gilead announced that it submitted a request to the FDA to rescind the orphan drug designation it had secured for remdesivir.

Consumer groups like Public Citizen had criticized Gilead for the designation.  Public Citizen said in an open letter to Gilead’s CEO that the status, which aims to incentivize research and development for treatments for rare diseases, would have enabled Gilead to “exclude competitors and charge high monopoly prices.”

Following its request to rescind its orphan drug designation for remdesivir, Gilead’s CEO Daniel O’Day released a statement in which he said that the company will “work to ensure affordability and access” to the drug if it is approved “so that remdesivir is available to patients with the greatest need.”

Multiple clinical trials are underway to study the drug’s effects in Covid-19 patients.  Initial results are on track to be reported in the coming weeks, according to O’Day.