-- Veklury is Currently Available in the
U.S. for the Treatment of Severe COVID-19 Under an Emergency Use
Authorization --
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for Veklury® (remdesivir), an investigational
antiviral for the treatment of patients with COVID-19. Veklury is
currently available in the U.S. under an Emergency Use
Authorization for the treatment of hospitalized patients with
severe COVID-19. The filing is the final tier of the rolling NDA
submission that was initiated on April 8, 2020.
The filing is supported by data from two randomized, open-label,
multi-center Phase 3 clinical studies of Veklury conducted by
Gilead and the Phase 3 randomized, placebo-controlled study of
Veklury conducted by the National Institute of Allergy and
Infectious Diseases (NIAID). These studies demonstrated that
treatment with Veklury led to faster time to recovery compared with
placebo and that a 5-day or 10-day treatment duration led to
similar clinical improvement. Across studies, Veklury was generally
well-tolerated in both the 5-day and 10-day treatment groups, with
no new safety signals identified.
“Since the beginning of the pandemic, Gilead has worked with
urgency to establish the efficacy and safety profile of Veklury,
and we now have a robust data set supporting the evaluation of use
of the drug across a range of hospitalized COVID-19 patient
populations,” said Merdad Parsey, MD, PhD, Chief Medical Officer,
Gilead Sciences. “Today’s filing is an important milestone as we
continue to partner with the U.S. government and healthcare
authorities around the globe to address the treatment needs of
patients with COVID-19.”
Veklury has been approved by multiple regulatory authorities
around the world, including in the European Union and Japan. In
countries where Veklury has not been approved, including the United
States, Veklury is an investigational drug and the safety and
efficacy of remdesivir have not been established. Please see below
for additional important warnings and information about the
authorized use of Veklury in the United States.
About Veklury
Veklury (remdesivir) is an investigational nucleotide analog
with broad-spectrum antiviral activity both in vitro and in vivo in
animal models against multiple emerging viral pathogens. Multiple
ongoing international Phase 3 clinical trials are evaluating the
safety and efficacy of Veklury for the treatment of SARS-CoV-2
infection, the virus that causes COVID-19, in different patient
populations, formulations, and in combination with other
therapies.
Important Information about Veklury in
the United States
In the United States, Veklury (remdesivir) is authorized for use
under an Emergency Use Authorization (EUA) only for the treatment
of patients with suspected or laboratory-confirmed SARS-CoV-2
infection and severe COVID-19. 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). Veklury
must be administered via intravenous (IV) infusion and is supplied
two ways: Veklury (remdesivir) for injection, 100 mg, lyophilized
powder, or Veklury (remdesivir) injection, 100 mg/20 mL (5 mg/mL),
concentrated solution.
Veklury is an investigational drug that has not been approved by
the FDA for any use, and the safety and efficacy of Veklury for the
treatment of COVID-19 have not been established. This authorization
is temporary and may be revoked, and does not take the place of the
formal new drug application submission, review and approval
process. For information about the authorized use of Veklury and
mandatory requirements of the EUA in the U.S., please review the
Fact Sheets and FDA Letter of Authorization available at
www.gilead.com/remdesivir.
There are limited clinical data available for Veklury. Serious
and unexpected adverse events may occur that have not been
previously reported with Veklury use. Hypersensitivity reactions,
including infusion-related and anaphylactic reactions, have been
observed during and following administration of Veklury. The use of
Veklury is contraindicated in patients with known hypersensitivity
to remdesivir. Transaminase elevations have been observed in
healthy volunteers and patients with COVID-19 in clinical trials
who received Veklury. 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 Veklury; additionally
monitor serum chemistries and hematology daily during therapy. Do
not initiate Veklury in patients with ALT ≥5x ULN or with an eGFR
<30 mL/min. The decision to continue or discontinue Veklury
therapy after development of an adverse event should be made based
on the clinical risk/benefit assessment for the individual
patient.
Due to a risk of reduced antiviral activity, coadministration of
Veklury and chloroquine phosphate or hydroxychloroquine sulfate is
not recommended.
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 Veklury treatment
and considered to be potentially attributable to Veklury. 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.
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.
For more information on Gilead’s response to the coronavirus
outbreak please visit the company’s dedicated page:
https://www.gilead.com/purpose/advancing-global-health/covid-19.
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.
Veklury (remdesivir) is an investigational drug that has not been
approved by the FDA for any use, and it is not yet known if Veklury
is safe or effective for the treatment of COVID-19. There is the
possibility of unfavorable results from ongoing and additional
clinical trials involving Veklury and the possibility that Gilead
and other parties 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 Veklury or that FDA and other regulatory
agencies may not approve Veklury, and any marketing approvals, if
granted, may have significant limitations on its use. As a result,
Veklury may never be successfully commercialized. In addition,
Gilead may be unable to sufficiently scale up the production of
Veklury 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 Quarterly
Report on Form 10-Q for the quarter ended June 30, 2020, 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 the emergency use of
Veklury (remdesivir) in the United States, please see the Emergency
Use Authorization Fact Sheets available at
www.gilead.com/remdesivir.
Gilead, the Gilead logo and Veklury 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
(@GileadSciences) 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/20200810005486/en/
Douglas Maffei, Ph.D., Investors (650) 522-2739
Sonia Choi, Media (650) 425-5483
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