USA – Gilead’s withdrawal of orphan status of COVID-19 candidate

Gilead Sciences’ investigational antiviral drug remdesivir has been saddled with high hopes as drugmakers search for a possible COVID-19 treatment. But after the FDA made the controversial decision to name remdesivir an orphan drug—a tag that comes with years of market exclusivity—Gilead bowed to critics’ outrage and asked for an out.

Gilead has asked the FDA to rescind its newly granted orphan drug designation for COVID-19 candidate remdesivir following a wave of backlash over the decision, including pushback from presidential candidate Sen. Bernie Sanders of Vermont.

The drugmaker argued in a statement that it didn’t require the FDA’s tag to secure an expedited review for remdesivir as a treatment for COVID-19, making no mention of the seven-year market exclusivity that comes with that designation…