Remdesivir maker 'moving very quickly' with FDA on possible coronavirus use, CEO says
The maker of Remdesivir, an experimental drug for treatment of the coronavirus, is moving very quickly with the FDA for authorization to get the drug to patients, the CEO of the company, Gilead Sciences, said Friday.
Gilead is also working to expand its capacity for producing remdesivir, CEO Daniel O'Day told the "TODAY" show in an exclusive interview.
The company thinks it could make millions of treatment courses available by the end of the year, O'Day said. Its production capacity has already gone from 5,000 treatment courses to 100,000, he said.
"We made the decision to expand capacity before we knew it was going to be effective," he said.
At the same time, Gilead and the Food and Drug Administration's collaboration "has been terrific" on possible emergency-use authorization for remdesivir as a coronavirus treatment, O'Day said.
"I expect that they're going to act very quickly," O'Day said, "and we’re prepared as a company to make sure we get this medicine to as many patients as possible as soon as possible after that approval."
O'Day noted that remdesivir currently is for "severe" coronavirus patients, who are hospitalized, but the company's scientists are exploring if the medication could help patients in earlier stages of the illness. "We’ll work hard on that," he said.
He also said Gilead is dedicated to making sure the treatment would be "affordable and accessible to patients around the world."
The CEO's comments come after Dr. Anthony Fauci, head of the National Institutes of Allergy and Infectious Diseases, said Wednesday that the drug has a proven benefit in treatment of the virus.
"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery," Fauci said at the White House on Wednesday. He was referring to a large study of more than 1,000 patients from multiple sites around the world in which patients received either the drug or a placebo.
Fauci said the remdesivir study group was able to be discharged from the hospital within 11 days, on average, compared to 15 days in the placebo group.
"What it has proven is that a drug can block this virus," Fauci said of the research.
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There were indications the antiviral drug led to fewer deaths, but that part of the analysis is still under review.
The study raised questions about whether the Food and Drug Administration would issue emergency use authorization for remdesivir, which would expand doctors' ability to use it.
In a statement to NBC News, an FDA official said, "the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate." It was unclear whether the FDA would take immediate action.
Gilead has been enrolling patients for robust clinical trials on remdesivir.
Prior to COVID-19, previous research in animals had shown the drug might treat MERS, another type of coronavirus. It was also widely promoted as a potential treatment for Ebola, but failed to show any significant benefit.