FDA Approves Remdesivir as COVID-19 Drugs In US

Gilead Science Inc, maker of the coronavirus drug remdesivir said it will be donating 1.5 million vials of the drug to help patients in U.S. Hospitals.

Chief Executive of the company Daniel O’Day made the pledge during a meeting with President Donald Trump on Friday.

The meeting came after the drug was granted emergency use authorization by the U.S. Food and Drug Administration for COVID-19.

The FDA approval cleared the way for broader use of the drug in more hospitals around the United States.

But the authorization applies to patients hospitalized with severe COVID-19 who require oxygen supplementation.

Gilead’s donation is expected to be enough for at least 140,000 patients, depending on the number of days they need to be treated.

The company said on Wednesday the drug, which is given by intravenous infusion, had helped improve outcomes for patients with COVID-19, the respiratory disease caused by the novel coronavirus.

Provided data suggested it worked better when given earlier in the course of infection.

With many countries reeling from the coronavirus pandemic, interest in Gilead’s drug has been high because there are currently no approved treatments or preventive vaccines for COVID-19.

Doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in extremely severe cases.

“It’s the first authorized therapy for COVID-19, so we’re really proud to be part of it,” FDA Commissioner Stephen Hahn said during the meeting.

Data released this week from a trial by the National Institutes of Health (NIH) in the United States showed that remdesivir reduced hospitalization stays by 31% compared to a placebo treatment, but did not significantly improve survival.

Gilead did not immediately respond to a request for the price it plans to charge for the drug after its pledged donations are used up.

The Institute for Clinical and Economic Review, which assesses effectiveness of drugs to determine appropriate prices, put the cost of producing a 10-day course of remdesivir at $10.

But it suggested that the price would rise to $4,500 based on patient benefits shown in clinical trials.