[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 10:21:04 PDT 2020

Gilead folds.  Acknowledges it only made the request in "Early March"..
well after it was clear the pandemic was not contained.


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.

More information about the Ip-health mailing list