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FDA approves COVID-19 drug on emergency basis

Bay Area

STANFORD, Calif. (KRON) — The FDA has approved a drug on an emergency basis for the treatment of COVID-19.

The drug is called remdesivir and it comes from Foster City based Gilead Sciences.

The drug is authorized to be used with patients severely ill with the virus.

Stanford has two clinical trials of remdesivir. The focus is on safety, tolerability and efficacy. The studies were approved in record time.

“It tells us that the pandemic is affecting all of us and we really needed something that will work,” Dr. Aruna Subramanian said.

Dr. Aruna Subramanian is leading one of Stanford’s clinical trials of remdesivir — the drug that can help treat COVID-19.

Specifically, the drug blocks an enzyme the virus needs to replicate.

Friday, the Food and Drug Administration approved the drug on an emergency basis.

It is not the same as a full FDA approval, but a sign the FDA believes the benefits far outweigh its risks in certain patients.

“Even if it’s not perfect, even if it’s not a magic bullet, it’s nice to have something that improves the overall situation,” Dr. Subramanian said.

Since mid March, Stanford has been a part of two clinical studies, one global sponsored by the National Institutes of Health.

Participants were involved in two trials — one for severe COVID-19 patients, the other for moderately ill patients.

Dr. Subramanian is working on a smaller study with Gilead, based in Foster City.

Daniel O’Day, CEO of Gilead, speaking at the White House Friday announced the company will donate 1.5 million viles of the drug.

“We’ll be working with the government to determine on how best to distribute that in the United States,” O’Day said. “We’ll be working very closely to get that to patients.”

“1.5 million doses, depending on the course whether it’s a five day or ten day course, that could be as few as 140,000 cases,” Samantha Bastow, PharmD, BCPS said.

Bastow is a pharmacy solution advisor at Lumere, which provides hospitals with data to help them solve healthcare supply chain challenges.

“We still have to use this judiciously and understand the logistics behind which region we should be receiving this medication, which hospitals within those regions,” Bastow, PharmD, BCPS said.

Dr. Subramanian says researchers are still looking into the best timing for treatment.

“It looks like the earlier you give the drug, the more efficacious it’s going to be and who really benefits most and who is going to go on to develop severe symptoms and where could we target the drugs,” she said.

These studies found many COVID-19 patients went home faster after being on treatment. Researchers at Stanford are already planning for what the next drug might be to treat COVID-19.

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