Remdesivir is first COVID-19 treatment drug to get regulators’ approval

*Hospital patients who got treatment recovered five days faster, but antiviral medicine has not been shown to reduce COVID-19 deaths

Alexander Davis | ConsumerConnect

The United States (US) Food and Drug Administration approved Gilead Sciences Inc.’s antiviral therapy Remdesivir Thursday, October 22, 2020.

The latest endorsement makes the treatment drug the first drug to obtain formal clearance for treating the novel Coronavirus, says agency report.

Regulators had granted an emergency-use authorisation for Remdesivir earlier this year, and since then the drug has become a widely used therapy in hospitalised COVID-19 patients.

The US President Donald Trump used same drug when he was diagnosed with the virus earlier October, according to report.

The approval of Remdesivir, sold under the brand name Veklury, will allow Gilead to market the drug and talk about its benefits to doctors, nurses, and patients.

That could help solidify its position as a go-to medicine for COVID-19 patients even as other drugs for the disease begin to reach the market.

Gilead in a statement said: “Veklury is now the first and only approved COVID-19 treatment in the United States.”

While the drug was in short supply initially, Gilead said that the medicine is now widely available in hospitals across the country as manufacturing capacity has rapidly expanded.

However, the drug has not been proved to reduce deaths from COVID-19.

In a World Health Organisation (WHO) trial, the medicine failed to reduce fatalities, according to preliminary results that were posted on preprint servers recently.

Gilead has criticised the WHO study. In a letter posted on the company’s website, Chief Medical Officer Merdad Parsey said the findings do not negate other results.

The approval is based on a U.S. government-sponsored trial involving more than 1,000 hospitalised Coronavirus patients that found that those who received the drug recovered about five days faster than those who got a placebo.

The overall side-effect rate was similar to the placebo in the government study.

The most common side effects are nausea and elevated liver enzymes, according to the product’s label.

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