-- Authorization Enables Broader Use of
Remdesivir to Treat Hospitalized Patients with Severe COVID-19
Disease in the United States --
-- Based on Patients’ Severity of Disease,
Authorization Allows 5-day and 10-day Treatment Durations
--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
U.S. Food and Drug Administration (FDA) has granted emergency use
authorization (EUA) for the investigational antiviral remdesivir to
treat COVID-19. The EUA will facilitate broader use of remdesivir
to treat hospitalized patients with severe COVID-19 disease,
enabling access to remdesivir at additional hospitals across the
country. Allocation of the currently limited available supply of
remdesivir will be made based on guiding principles that aim to
maximize access for appropriate patients in urgent need of
treatment, with direction from and in collaboration with the
government.
Remdesivir is authorized for the treatment of hospitalized
patients with severe COVID-19 disease. The optimal duration of
treatment is still being studied in ongoing clinical trials. Under
the EUA, both 5-day and 10-day treatment durations are suggested,
based on the severity of disease. The authorization is temporary
and does not take the place of the formal new drug application
submission, review and approval process. The EUA allows for the
distribution and emergency use of remdesivir only for the treatment
of COVID-19; remdesivir remains an investigational drug and has not
been approved by FDA.
The U.S. government will coordinate the donation and
distribution of remdesivir to hospitals in cities most heavily
impacted by COVID-19. Given the severity of illness of patients
appropriate for remdesivir treatment and the limited availability
of drug supply, hospitals with intensive care units and other
hospitals that the government deems most in need will receive
priority in the distribution of remdesivir. Gilead is working with
the U.S. government on the logistics of remdesivir distribution and
will provide more information when the company begins shipping the
drug under the EUA.
“This EUA opens the way for us to provide emergency use of
remdesivir to more patients with severe symptoms of COVID-19,” said
Daniel O’Day, Chairman and Chief Executive Officer of Gilead
Sciences. “We will continue to work with partners across the globe
to increase our supply of remdesivir while advancing our ongoing
clinical trials to supplement our understanding of the drug’s
profile. We are working to meet the needs of patients, their
families and healthcare workers around the world with the greatest
sense of urgency and responsibility.”
The EUA is based on available data from two global clinical
trials – the National Institute for Allergy and Infectious
Diseases’ placebo-controlled Phase 3 study in patients with
moderate to severe symptoms of COVID-19, including those who were
critically ill, and Gilead’s global Phase 3 study evaluating 5-day
and 10-day dosing durations of remdesivir in patients with severe
disease. Multiple additional clinical trials are ongoing to
generate more data on the safety and efficacy of remdesivir as a
treatment for COVID-19.
Remdesivir must be administered intravenously. The optimal
dosing and duration of remdesivir for the treatment of COVID-19 is
still unknown. Under this EUA, the 10-day dosing duration is
suggested for patients requiring invasive mechanical ventilation
and/or extracorporeal membrane oxygenation (ECMO), and the 5-day
dosing duration is suggested for patients not requiring invasive
mechanical ventilation and/or ECMO. If a patient on the 5-day
dosing duration does not demonstrate clinical improvement after
five days, treatment may be extended for up to five additional days
(10 days total).
As previously announced, Gilead has donated the entirety of its
existing supply of finished and unfinished product to help address
the urgent medical needs posed by this pandemic around the world.
Assuming a 10-day treatment course, Gilead’s donation of 1.5
million individual doses of remdesivir equates to more than 140,000
treatment courses that will be provided at no cost to treat
patients following potential emergency authorizations and
regulatory approvals, including this EUA. Gilead will continue to
support clinical trials, and expanded access and compassionate use
programs for remdesivir. In addition, Gilead will evaluate global
allocation of supply on an ongoing basis using multiple,
independent data sources to track the incidence and severity of the
outbreak.
An EUA is intended to provide availability of a medicine during
an emergency; an EUA is not the equivalent of an FDA approval. See
below for important information about remdesivir.
Scale-Up of Remdesivir
Supply
Gilead has aggressively implemented a multipronged approach to
scale up production and rapidly build supply of the investigational
antiviral remdesivir. The company has invested significant capital,
at risk, to meet the supply needs for clinical trials and emergency
treatment programs, and to prepare for even greater demand
following regulatory authorizations, should these occur.
Through process refinements, Gilead has substantially shortened
the manufacturing lead time from raw materials through to finished
product. Gilead has also supplemented internal manufacturing with
significant additional capacity from multiple partners in North
America, Europe and Asia. The company has set a goal of producing
at least 500,000 treatment courses by October, 1 million treatment
courses by December 2020 and millions more in 2021, if required.
These goals were based on a 10-day treatment course. Gilead now
anticipates being able to cover significantly more patients based
on the SIMPLE study results, which demonstrated similar efficacy
with 5-day and 10-day dosing durations in patients with severe
disease. Looking ahead, Gilead is building a geographically diverse
consortium of leading pharmaceutical and chemical manufacturing
companies to help reach and exceed manufacturing goals, and go
above and beyond what any company could do individually. More
details about these efforts are available here.
Important Information about
Remdesivir
Remdesivir (GS-5734™) is authorized for use under an EUA only
for the treatment of patients with suspected or
laboratory-confirmed SARS-CoV-2 infection and severe COVID-19
disease. SARS-CoV-2 is the coronavirus that causes COVID-19
disease. Severe disease is defined as patients with an oxygen
saturation (SpO2) ≤ 94% on room air or requiring supplemental
oxygen or requiring mechanical ventilation or requiring
extracorporeal membrane oxygenation (ECMO). Remdesivir is
authorized for adult or pediatric patients who are admitted to a
hospital and for whom use of an IV agent is clinically appropriate,
as remdesivir must be administered intravenously.
Remdesivir is an investigational drug that has not been approved
by the FDA for any use. It is not yet known if remdesivir is safe
and effective for the treatment of COVID-19.
There are limited clinical data available for remdesivir.
Serious and unexpected adverse events may occur that have not been
previously reported with remdesivir use. Warnings: In clinical
studies with remdesivir, infusion-related reactions and liver
transaminase elevations have been observed. Remdesivir should not
be used in patients who are hypersensitive to any ingredient of
remdesivir. If signs and symptoms of a clinically significant
infusion reaction occur, immediately discontinue administration of
remdesivir and initiate appropriate treatment. Patients should have
appropriate clinical and laboratory monitoring to aid in early
detection of any potential adverse events. Monitor renal and
hepatic function prior to initiating and daily during therapy with
remdesivir; additionally monitor serum chemistries and hematology
daily during therapy. The decision to continue or discontinue
remdesivir therapy after development of an adverse event should be
made based on the clinical risk benefit assessment for the
individual patient.
Healthcare providers and/or their designee are responsible for
mandatory FDA MedWatch reporting of all medication errors and
serious adverse events or deaths occurring during remdesivir
treatment and considered to be potentially attributable to
remdesivir. These events must be reported within 7 calendar days
from the onset of the event. MedWatch adverse event reports can be
submitted to FDA online at www.fda.gov/medwatch or by calling
1-800-FDA-1088.
This is not all of the important information for remdesivir. The
FDA has authorized distribution of this medicine with accompanying
Fact Sheets, which can be accessed at www.gilead.com/remdesivir.
Healthcare providers should review the Fact Sheet for Healthcare
Providers for more information on the authorized use of remdesivir
and mandatory requirements of the EUA.
The distribution of remdesivir has been authorized only for the
treatment of COVID-19. It is not authorized for the treatment of
any other viruses or pathogens. Information from the FDA about the
FDA-authorized emergency use of remdesivir is available at
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City,
California.
Forward-Looking
Statement
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of
1995, that are subject to risks, uncertainties and other factors.
Remdesivir is an investigational agent that has not been approved
by the FDA, and it has not been demonstrated to be safe or
effective for any use, including for the treatment of COVID-19.
There is the possibility of unfavorable results from ongoing and
additional clinical trials involving remdesivir and the possibility
that Gilead may be unable to complete one or more of such trials in
the currently anticipated timelines or at all. Further, it is
possible that Gilead may make a strategic decision to discontinue
development of remdesivir or that FDA and other regulatory agencies
may not approve remdesivir, and any marketing approvals, if
granted, may have significant limitations on its use. As a result,
remdesivir may never be successfully commercialized. In addition,
Gilead may be unable to sufficiently scale up the production of
remdesivir in the currently anticipated timelines, and Gilead may
be unable to meet future supply needs. These risks, uncertainties
and other factors could cause actual results to differ materially
from those referred to in the forward-looking statements. The
reader is cautioned not to rely on these forward-looking
statements. These and other risks are described in detail in
Gilead’s Annual Report on Form 10-K for the year ended December 31,
2019, as filed with the U.S. Securities and Exchange Commission.
All forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation to update any
such forward-looking statements.
For more information about remdesivir, please
see the Emergency Use Authorization Fact Sheets available at
www.gilead.com/remdesivir.
GS-5734, Gilead and the Gilead logo are
trademarks of Gilead Sciences, Inc. or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20200501005505/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Sonia Choi, Media (650) 425-5483
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