Gilead’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19
Food
& Drug Administration,United States of America on May 1,2020 authorised the
emergency use of investigational & under trial drug named as Remdesivir for
treatment of hospitalized patients with COVID-19.
Authorization
Enables Broader Use of Remdesivir to Treat Hospitalized Patients with Severe COVID-19 Disease.Based on Patients’ Severity of Disease, Authorization Allows
5-day and 10-day Treatment Durations.
History
of REMDESIVIR
Remdesivir is
a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead
Sciences. Earlier studies found antiviral activity against several RNA
viruses including SARS coronavirus and Middle East
respiratory syndrome-related coronavirus, but it is not currently approved for
any indication.Remdesivir was originally developed to treat Ebola virus
disease and Marburg virus disease but was ineffective for these
viral infections.
As
of 2020, remdesivir is under investigation as a specific treatment
for COVID-19, and has been authorised by the US Food and Drug
Administration (FDA) for emergency treatment for those hospitalized with severe
disease.It may have an effect on the time it takes to recover from the disease.
Drug
Details(pharmacology)
Remdesivir
is an investigational antiviral compound undergoing clinical
trials in a number of countries as a potential treatment for COVID-19. Remdesivir
is a nucleoside ribonucleic acid (RNA) polymerase inhibitor.It is a direct
acting antiviral drug that inhibits viral RNA synthesis. It is an investigational
drug and is not currently approved for any indication.It has activity in cell
culture and animal models against SARS-CoV, MERS-CoV, and SARS-CoV-2.
Targeted patients
·
The remdesivir
covered by this authorization will be used only to treat adults and children
with suspected or laboratory confirmed COVID-19 and severe disease defined as
SpO2 ≤ 94% on room air, requiring supplemental oxygen, mechanical ventilation,
or extracorporeal membrane oxygenation (ECMO).
·
Remdesivir is
administered in an in-patient hospital setting via intravenous (IV) infusion by
a healthcare provider.
Product
Description
Remdesivir
is a nucleoside ribonucleic acid (RNA) polymerase inhibitor.
Remdesivir
for injection, 100 mg, is a sterile, preservative-free lyophilized solid that
is to be reconstituted with 19mL of sterile water for injection and diluted
into 0.9% saline prior to intravenous (IV) administration.
Following
reconstitution, each single-dose, clear glass vial contains a 5 mg/mL
remdesivir concentrated solution with sufficient volume to allow withdrawal of
20 mL. Remdesivir Injection, 5 mg/mL, is a sterile, preservative- free, clear,
solution that is to diluted into 0.9% saline prior to intravenous (IV)
administration.
The
authorized remdesivir vial label and/or the carton labeling is clearly marked
for “emergency use authorization” or for “investigational use.”
Storage
of Drug
Remdesivir
for injection, 100 mg, vials should be stored below 30 °C until time of use.
Remdesivir
injection, 5 mg/mL vials should be stored at refrigerated temperatures (2 °C to
8 °C) until time of use.
Following
dilution with 0.9% saline, the solution can be stored for up to 4 hours at room
temperature (20 °C to 25 °C) or 24 hours at refrigerated temperatures (2 °C to
8 °C).
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