FDA approves first drug to treat COVID-19

FDA approves first drug to treat COVID-19

U.S. regulators on Thursday approved the first drug to treat Covid-19: remdesivir, an antiviral medicine given to hospitalised patients through an IV.

Remdesivir, given intravenously, was one of the drugs used to treat US President Donald Trump during his bout with Covid-19.

It had been authorized for use on an emergency basis since spring, and now has become the first drug to win full USA approval for treating COVID-19.

The approval is based on a USA government-sponsored trial involving more than 1,000 hospitalized coronavirus patients that found that those who received the drug recovered about five days faster than those who got a placebo. For patients younger than 12, the FDA will still allow the drug's use in certain cases under its previous emergency authorization. It works by blocking the virus's ability to make more copies of itself. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness. 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.

The company said Veklury has regulatory approvals or temporary authorisations in about 50 additional countries.

None of the studies have found the drug can improve survival rates.

"The formal FDA approval doesn't change our (sales) estimates or outlook for remdesivir given it has already been branded standard-of-care prior to formal approval", Raymond James analyst Steven Seedhouse said in a research note, calling the prescribing guidelines and approval "pretty much a best case for Gilead", given the World Health Organization results questioning remdesivir's benefits.

The FDA approval comes days after a study from the World Health Organization found no benefit of the drug in reducing early death or in preventing progression to serious disease among almost 3000 COVID-19 patients. The amount that patients pay out of pocket depends on insurance, income and other factors.

Dexamethasone, a low-priced steroid now widely used on Covid patients in intensive care in the United Kingdom, was not included in this study. The FDA also has given emergency authorisation to using the blood of survivors, and two companies are now seeking similar authorisation for experimental antibody drugs.

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