European Commission Grants Conditional Marketing Authorization for Gilead’s Veklury® (remdesivir) for the Treatment of COV...
July 03 2020 - 7:56AM
Business Wire
-- Veklury is the First Approved
Treatment Option for COVID-19 in the European Union --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
European Commission has granted conditional marketing authorization
for Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection,
the virus that causes COVID-19. The conditional marketing
authorization was granted in the interest of public health due to
the COVID-19 pandemic and was based on a rolling review of
supporting data that began in April 2020.
Under this authorization, Veklury is indicated for the treatment
of COVID-19 in adults and adolescents (aged 12 years and older and
weighing at least 40 kg), with pneumonia requiring supplemental
oxygen.
“We appreciate the European Medicines Agency’s rapid review of
remdesivir in recognition of the unprecedented nature of this
pandemic,” said Merdad Parsey, MD, PhD, Chief Medical Officer,
Gilead Sciences. “This conditional marketing authorization is an
important step forward as we work together to address the treatment
needs of patients across Europe.”
Veklury has been studied in hospitalized COVID-19 patients
spanning a range of disease severity. The conditional marketing
authorization for Veklury is supported by the U.S. National
Institute of Allergy and Infectious Diseases’ global Phase 3 trial
of remdesivir. A conditional marketing authorization in Europe is
initially valid for one year but can be extended or converted into
an unconditional marketing authorization after the submission and
assessment of additional confirmatory data.
Ongoing clinical trials continue to evaluate the safety and
efficacy of remdesivir, including studies of remdesivir in
combination with anti-inflammatory medicines and in special
populations including pediatric patients. Research is also being
conducted on new, investigational formulations of remdesivir that
may enable studies of remdesivir in earlier stages of disease.
About
Veklury
Veklury (remdesivir) is a 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 remdesivir for the treatment of SARS-CoV-2, the virus
that causes COVID-19. In recognition of the current public health
emergency and based on available clinical data, remdesivir has been
approved as a treatment for patients with severe COVID-19 in Japan,
Taiwan, India, Singapore, the United Arab Emirates and the European
Union. Outside of these regions, remdesivir is an investigational,
unapproved drug.
Important Information about Remdesivir
in the United States
In the United States, remdesivir (GS-5734™) 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). 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, and the safety and efficacy of remdesivir
for the treatment of COVID-19 have not been established. This
authorization is temporary and may be revoked, and it does not take
the place of the formal new drug application submission, review and
approval process. For information about the authorized use of
remdesivir and mandatory requirements of the EUA in the United
States, please review the Fact Sheets and FDA Letter of
Authorization available at www.gilead.com/remdesivir.
There are limited clinical data available for remdesivir.
Serious and unexpected adverse events may occur that have not been
previously reported with remdesivir use. Hypersensitivity
reactions, including infusion-related and anaphylactic reactions,
have been observed during and following administration of
remdesivir. The use of remdesivir 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 remdesivir. 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. Do not initiate remdesivir in patients with
ALT ≥5x ULN or with an eGFR <30 mL/min. 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.
Due to a risk of reduced antiviral activity, coadministration of
remdesivir 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 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.
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.
Gilead 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,
including the risk that the European Commission may not extend or
convert the conditional marketing authorization into an
unconditional marketing authorization for Veklury as a treatment
for COVID-19. Remdesivir is an investigational drug that has not
been approved by the FDA 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 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 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. 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 March 31, 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.
Veklury, 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
(@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/20200703005116/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Sonia Choi, Media (650) 425-5483
Sarah Swift, Media – Europe +44 208 587 2618
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