Potentially lifesaving coronavirus treatment dexamethasone could have ‘immediate impact,’ former FDA chief says

A cheap steroid called dexamethasone could have an “immediate impact” on how doctors treat the most severe cases of Covid-19, potentially reducing the mortality rate of the disease, former Food and Drug Administration Commissioner Dr. Scott Gottlieb said Tuesday.

In one study, the drug cut the risk of death by a third for Covid-19 patients on ventilators and by a fifth for those on supplemental oxygen. The underlying data from the study has yet to be published, but the U.K. researchers who led the trial described the results as “ground-breaking.”

“It’s going to probably have an immediate impact on what doctors are doing in the ICU setting,” Gottlieb said Tuesday on CNBC’s “Squawk Box” in response to the news. “This is an important finding. It’s going to change dogma.”

Dexamethasone, a steroid medication, is cheap, widely available and doctors are already accustomed to prescribing it, Gottlieb said. He noted that more research is needed to confirm the study’s findings, but that the trial was “well designed.”

The drug is the first to show signs that it can improve survival among Covid-19 patients, the researchers said. The treatment, in conjunction with other medical findings doctors have learned about how to treat Covid-19 patients, Gottlieb said, will likely make the disease less fatal overall than it was in the months after it emerged.

While most people infected with the coronavirus appear to develop only mild symptoms, according to data from the Centers for Disease Control and Prevention, some will require hospitalization. The risk of severe disease appears to increase with age, according to data from the CDC, and for those with underlying medical conditions.

The coronavirus has infected more than 8.06 million people around the world, killing at least 437,532 people, according to data compiled by Johns Hopkins University.

The study on dexamethasone came out of the U.K.-led Recovery trial, a large, randomized, controlled trial of a variety of coronavirus treatments. The researchers treated more than 2,000 hospitalized patients with dexamethasone and compared their outcomes with more than 4,000 patients who received “usual care alone.”

“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” Peter Horby, an Oxford University professor and one of the chief investigators for the trial, said in a statement. “The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment, so dexamethasone should now become standard of care in these patients.”

The researchers said the drug does not appear to benefit patients with more mild symptoms.

Dexamethasone is a well-known anti-inflammatory drug that has been used since the early 1960s to treat arthritis, asthma, allergic reactions and other conditions. The drug can be administered orally or by intravenous injection, the researchers said. 

“This is a result that shows that if patients who have Covid-19 and are on ventilators or are on oxygen are given dexamethasone, it will save lives, and it will do so at a remarkably low cost,” said Martin Landray, an Oxford University professor who is co-leading the trial.

There is still no drug that has been proven effective and approved by the U.S. FDA for the treatment of Covid-19. Gilead’s remdesivir has received an emergency use authorization for the treatment of the disease and early studies have indicated it can shorten the recovery time for patients. 

Remdesivir, unlike dexamethasone, is a new drug with a limited supply, which has hampered efforts to quickly distribute it to health-care providers. If researchers are able to replicate the results of the Recovery trial, Gottlieb said it could help save lives. 

“This is a very positive finding and it’s a robust finding. It’s a well-done study,” Gottlieb said. “It certainly suggests that this could be beneficial in this setting. This is an important finding here today.”

Disclosure: Scott Gottlieb is a CNBC contributor and is a member of the boards of Pfizer and biotech company Illumina.

Correction: Scott Gottlieb spoke to CNBC on Tuesday. An earlier version misstated the day.

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