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27 March 2020, 08:58
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Gilead withdraws their Orphan Drug Status application for hope COVID-19 treatment, Remdesivir.

Gilead withdraws their Orphan Drug Status application for hope COVID-19 treatment, Remdesivir. - picture 1

As we reported earlier this week the US Food & Drug Administration (FDA) granted Gilead Sciences' application to grant their antiviral treatment, Remdesivir, Orphan Drug Status.

The new status, intended for drugs to treat the rarest of diseases, would have seen Gilead Sciences take exclusive control over manufacturing and pricing of the promising COVID-19 treatment - a move that could have potentially have restricted access for millions of people during a pandemic.

Yesterday, however, Gilead Sciences asked the FDA to revoke the special status after facing backlash from medical bodies and community organisations around the world.

In a statement Gilead Sciences said:

Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits that accompany the designation. Gilead 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.

In early March, Gilead sought and was subsequently granted an orphan drug designation for the remdesivir as a potential treatment for COVID-19. Orphan drug designation is granted by the FDA in situations where the disease affects fewer than 200,000 patients in the United States.

Among the benefits of orphan drug designation, this status results in a waiver of 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.

Gilead recognises 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.

Gilead shares fell 5.8% on the news.

Author: Tom Hayes

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