SILVER SPRING, Md.,
Jan. 21, 2022 /PRNewswire/ -- Today,
the U.S. Food and Drug Administration took two actions to expand
the use of the antiviral drug Veklury (remdesivir) to certain
non-hospitalized adults and pediatric patients for the treatment of
mild-to-moderate COVID-19 disease. This provides another treatment
option to reduce the risk of hospitalization in high-risk patients.
Previously, the use of Veklury was limited to patients requiring
hospitalization.
"On the heels of the FDA's recent authorization of two oral
antiviral drugs, today's actions bolster the arsenal of
therapeutics to treat COVID-19 and respond to the surge of the
omicron variant," said Patrizia
Cavazzoni, M.D., director of the FDA's Center for Drug
Evaluation and Research. "Today's actions provide adults and
pediatric patients, with mild-to-moderate COVID-19 who are at high
risk of severe COVID-19, with a treatment option they could receive
outside of a traditional inpatient hospital setting, including at
skilled nursing facilities, home healthcare settings and outpatient
facilities such as infusion centers."
Veklury is not a substitute for vaccination in individuals for
whom COVID-19 vaccination and a booster dose are recommended. The
FDA has approved one vaccine and authorized others to prevent
COVID-19 and the serious clinical outcomes associated with
COVID-19, including hospitalization and death. The FDA urges the
public to get vaccinated and receive a booster if eligible. Learn
more about FDA-approved or -authorized COVID-19 vaccines.
The FDA has expanded the approved indication for Veklury to
include its use in adults and pediatric patients (12 years of age
and older who weigh at least 40 kilograms, which is about 88
pounds) with positive results of direct SARS-CoV-2 viral testing,
and who are not hospitalized and have mild-to-moderate COVID-19,
and are at high risk for progression to severe COVID-19, including
hospitalization or death.
The agency also revised the Emergency Use Authorization (EUA)
for Veklury to additionally authorize the drug for treatment of
pediatric patients weighing 3.5 kilograms to less than 40 kilograms
or pediatric patients less than 12 years of age weighing at least
3.5 kilograms, with positive results of direct SARS-CoV-2 viral
testing, and who are not hospitalized and have mild-to-moderate
COVID-19, and are at high risk for progression to severe COVID-19,
including hospitalization of death.
Based on today's actions, these high-risk non-hospitalized
patients may receive Veklury via intravenous infusion for a total
of three days for the treatment of mild-to-moderate COVID-19
disease.
The approval of Veklury for use in non-hospitalized patients is
supported by a randomized, placebo-controlled clinical
trial that included 562 non-hospitalized patients with
mild-to-moderate COVID-19 who were at high risk for progression to
severe COVID-19, including hospitalization or death. The main
outcome measured in the trial was whether a patient was
hospitalized for any COVID-19 related reason or died from any
reason within 28 days of treatment. Overall, 2 of 279 patients who
received Veklury (0.7%) required COVID-19 related hospitalization
compared to 15 of 283 patients who received a placebo (5.3%). There
were no deaths in either group.
Pediatric patients for whom Veklury is authorized will receive
doses adjusted for their body weight in order to achieve comparable
exposures to adults and pediatric patients receiving the approved
dose. Given the similar course of COVID-19 disease, the
authorization of Veklury in certain pediatric patients is based on
extrapolation of efficacy from adequate and well-controlled studies
in adults.
Important details about using Veklury to treat COVID-19 for its
approved use is available in the prescribing information, which
includes dosing instructions, potential side effects and drug
interactions. Possible side effects include increased levels of
liver enzymes, which may be a sign of liver injury; and allergic
reactions, which may include changes in blood pressure and heart
rate, low blood oxygen level, fever, shortness of breath, wheezing,
swelling (e.g., lips, around eyes, under the skin), rash, nausea,
sweating or shivering. Similar safety information about using
Veklury to treat COVID-19 in certain non-hospitalized pediatric
patients under the EUA is available in the fact sheets
for health care
providers and parents/caregivers.
The FDA granted approval and reissued the revised EUA to Gilead
Sciences Inc.
Additional Resources:
- Remdesivir EUA Letter of Authorization
- Frequently Asked Questions for Veklury (remdesivir)
- Emergency Use Authorization: Drugs and Non-Vaccine Biological
Products
- Coronavirus Treatment Acceleration Program (CTAP)
- Coronavirus Disease (COVID-19)
- National Institutes of Health COVID-19 Treatment Guidelines for
High-Risk, Non-hospitalized Patients with Mild to Moderate
COVID-19
# # #
Media Contact: Chanapa Tantibanchachai,
202-384-2219
Consumer Inquiries: Email or 888-INFO-FDA
(888-463-0332)
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration