Remdesivir gets USFDA emergency approval: Covid-19

This was lighting speed in terms of getting something approved. From clinical trial to getting it authorized, it was 90 days: USFDA

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Remdesivir gets USFDA emergency approval for teating Covid-19

The US has allowed the emergency use of the experimental antiviral drug remdesivir to treat Covid-19 based on early clinical data that shows it helps coronavirus disease (Covid-19) patients recover faster.

R patientsemdesivir, manufactured by Gilead Sciences, is the world’s first drug approved based on clinical data to treat Covid-19, which has killed close to 240,000 people worldwide and infected over three million. Emergency-use authorization allows products to be used for treatment without full data on their safety and efficacy, which has to be still submitted as trial continue.

Lighting speed

This was lighting speed in terms of getting something approved. From clinical trial to getting it authorized, it was 90 days,” said US Food and drug Administration (FDA) Commissioner Stephen Hahn, speaking at the White House with President Donald Trump at his side.

Remdesivir, when administered by an intravenous infusion, helped patients recover on an average in 11 days, compared to 15 days taken by those on placebo. The emergency use of remdesivir is limited to hospitalised Covid-19 patients with low blood-oxygen levels or who need breathing support, the FDA said in its letter of authorisation.

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“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of remdesivir when used to treat Covid-19 outweigh the known and potential risks of such products; and there is no adequate, approved, and available alternative,” said the FDA in the letter.

A treatment will help tide the pandemic till an effective vaccine, now expected to be ready as early as six months, is available to protect against the disease and help reopen the economies and lower social-distancing restrictions, which have led to job losses, closed schools and wrecked global economy.

“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),” said FDA.

Hospitalised patients in need of oxygen support account for about 14% of Covid-19 patients, according to early studies of the outbreak. Patients on a mechanical ventilator or ECMO should be given the drug for 10 days, while those who are less sick should get it for five days, the company said.

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What is Remdesivir?

•Remdesivir is a nucleoside ribonucleic acid (RNA) polymerase inhibitor.
•Remdesivir for injection, 100 mg, is a sterile, preservative-free lyophilized solid that is 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.
•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).

Source: US FDA