[Ip-health] Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation

James Love james.love at keionline.org
Wed Mar 25 11:05:51 PDT 2020

The wayback machine has snapshots of the CDC "Coronavirus Disease 2019
(COVID-19) Situation Summary" by day, so you can see what was known, when
Gilead filed for Orphan status.


On Wed, Mar 25, 2020 at 1:21 PM James Love <james.love at keionline.org> wrote:

> Gilead folds.  Acknowledges it only made the request in "Early March"..
> well after it was clear the pandemic was not contained.
> https://www.gilead.com/-/media/gilead-corporate/files/pdfs/company-statements/remdesivir-orphan-drug-designation.pdf
> 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 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.

James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
http://www.keionline.org <http://www.keionline.org/donate.html>

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