FDA grants Gilead request to drop orphan drug designation for potential COVID-19 treatment remdesivir

The FDA on Wednesday withdrew an orphan drug designation it had granted Gilead Sciences a few days ago for its investigational antiviral remdesivir to treat COVID-19. The company, which had made the request, said it will waive all benefits that come with the designation, including an extra seven years of exclusivity for the medication, adding that it "recognises the urgent public health needs posed by the COVID-19 pandemic…[and is] confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir," without the special status.

Gilead explained that it had sought and was subsequently granted the designation for remdesivir earlier this month, drawing criticism from some health activists such as Public Citizen (for related analysis, see ViewPoints: Gilead under fire for declaring remdesivir an orphan drug). The company has said that when it made the application, "only a small number of Americans were affected by COVID-19," and also pointed out that it was "making significant at-risk investments to develop and manufacture" the drug as the pandemic spreads.

Aside from the extended exclusivity, Gilead noted that benefits of an orphan drug designation include waiving the need to provide a paediatric study plan prior to submitting a new drug application, "a process that can take up to 210 days to review."

Meanwhile, the Financial Times recently reported that AbbVie would be dropping its patent protection on the HIV drug Kaletra (lopinavir/ritonavir), another potential coronavirus treatment candidate.

Earlier this week, Gilead said it would temporarily suspend emergency access to remdesivir due to "overwhelming demand over the last several days." The experimental broad-spectrum antiviral is being evaluated as a potential treatment for patients with COVID-19 in several trials, including in the US and China.

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