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).