In May, a little-known antiviral medication called remdesivir became the first drug to be approved by the U.S. Food and Drug Administration (FDA) to treat the novel coronavirus (COVID-19).

Hacksensack Meridian Health has some important background information to share about it.

The FDA issued an emergency use authorization for remdesivir on May 1, in response to the preliminary results of a notable study that was released at the end of April. That study, which included more than 1,000 hospitalized patients with severe COVID-19, showed that patients who received remdesivir instead of placebo recovered 31 percent more quickly, allowing them to leave the hospital after about 11 days, instead of 15 days. The study was sponsored by the National Institutes of Health (NIH).

An emergency use authorization was necessary because remdesivir had never been FDA-approved to treat any condition. Because of this, the medication wasn’t available for use outside of an investigational (clinical trial) setting. Now, doctors nationwide may give remdesivir to any patients who are hospitalized with severe COVID-19, rather than limiting the drug’s usage to those patients who are participating in clinical trials.

“The FDA’s Emergency Use Authorization allowed for more COVID-19 patients to receive this promising drug,” said Ihor Sawczuk, M.D., FACS, the chief research officer and president of the Northern Region for Hackensack Meridian Health. “This could help a greater number of severely ill COVID-19 patients to recover more quickly.”

What was remdesivir used for in the past?

Remdesivir has always been considered an investigational drug. It’s never been used to treat any conditions, but it’s been studied as a potential treatment for several diseases. Originally, it was created as a possible treatment for hepatitis. In 2014, it was studied as a possible treatment for the Ebola virus. Since then, its effectiveness against other coronaviruses has been studied as the viruses emerged. Researchers found remdesivir to be effective against severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), although the studies were only done in test tubes and on animals, not in humans.

How is remdesivir given to COVID-19 patients?

The drug is given intravenously to hospitalized patients with severe COVID-19. Within the NIH-sponsored study, patients received the drug for 10 days. Under the emergency use authorization, patients may be given remdesivir treatments for either 5 or 10 days, depending on how severe their condition is.

“We are continuing to evaluate the drug – but it shows promise, thus far,” said Sawczuk. “When it comes to a new virus, we have to do everything we can to save patients.”

How does remdesivir help patients with COVID-19?

The drug prevents the virus from producing a particular enzyme that is necessary for the virus to replicate itself. Once this happens, the virus is no longer able to spread within the body.

Research has shown that remdesivir is able to shorten the duration of patient hospital stays. It’s also been associated with fewer deaths among severely ill COVID-19 patients.

Can anyone with COVID-19 get remdesivir?

Only severely ill hospitalized COVID-19 patients are eligible to be treated with remdesivir, according to the FDA’s emergency use authorization. At this time, people with milder cases of COVID-19 shouldn’t expect to receive this intravenous drug.

Remdesivir’s manufacturer recently donated its current supply of the drug to the U.S. government, to allow for patients nationwide to gain access to the medication more readily. After receiving the drug supply from the manufacturer, the U.S. Department of Health and Human Services created a plan to distribute remdesivir to state health departments nationwide. New Jersey was one of the first states to receive shipments of remdesivir, since it’s one of the states with the most COVID-19 cases.

“At Hackensack Meridian Health, we are involved in three remdesivir trials,” said Sawczuk. “All told, through these trials and compassionate and expanded uses, more than 250 COVID-19-positive patients have received this antiviral drug.”

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