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Regulatory Focus™ > News Articles > 2020 > 3 > Gilead Asks FDA to Rescind Orphan Designation for COVID-19 Antiviral

Gilead Asks FDA to Rescind Orphan Designation for COVID-19 Antiviral

Posted 25 March 2020 | By Zachary Brennan 

Gilead Asks FDA to Rescind Orphan Designation for COVID-19 Antiviral

In a reversal, Gilead said Wednesday that it submitted a request to the US Food and Drug Administration (FDA) to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19.

Earlier in March, Gilead was granted the designation because the potential antiviral would help to treat COVID-19, which currently affects fewer than 200,000 patients in the US. If the company had kept the designation and remdesivir won approval, the treatment would have received seven years of orphan drug exclusivity (although the patents on remdesivir will last for longer than seven years) and tax credits for some of the research done on remdesivir. Still, criticism of the designation was widespread, especially as the number of COVID-19 cases grows.

But now Gilead said it is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir without the orphan drug designation. “Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited,” the company said.

Gilead further noted that among the benefits of orphan drug designation is that FDA can waive the requirement to provide a pediatric study plan prior to the submission of a New Drug Application – a process that can to take up to 210 days to review. 

According to FDA’s draft guidance on submitting pediatric study plans, sponsors should submit such study plans before the initiation of any Phase 3 studies, which Gilead has initiated for remdesivir, and FDA can grant waivers and/or deferrals of required pediatric assessments.

“Gilead recognizes the urgent public health needs posed by the COVID-19 pandemic. The company is working to advance the development of remdesivir as quickly as possible, and will provide updates as they become available,” the company said in a statement.

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