US allows drug to aid virus recovery

The National Institutes of Health’s Dr Anthony Fauci said the drug would become a new standard of care for severely ill COVID-19 patients. Remdesivir, which blocks an enzyme the virus uses to copy its genetic material, has not been tested on people with milder illness.

The FDA authorized the drug under its emergency powers to quickly speed the availability of experimental drugs, tests and other medical products during public health crises.

In normal times the FDA requires “substantial evidence” of a drug’s safety and effectiveness, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can waive those standards and require only that an experimental treatment’s potential benefits outweigh its risks.

Gilead has said it will donate its currently available stock of the drug and is ramping up production to make more. It said the US government would coordinate distribution of remdesivir to parts of the country that need it most.

No drugs are currently FDA-approved for treating the coronavirus, and remdesivir will still need formal approval.

The FDA can convert the drug’s status to full approval if Gilead or other researchers provide additional data of remdesivir’s safety and effectiveness.

“This is a very, very early stage so you wouldn’t expect to have any sort of full approval at this point,” said Cathy Burgess, an attorney specializing in FDA issues. “But obviously they want to get this out to patients as quickly as possible.”

The FDA previously allowed narrow use of a malaria drug, hydroxychloroquine, for hospitalized patients who were unable to take part in ongoing studies of the medication. Trump repeatedly promoted it as a possible COVID-19 treatment, but no large high-quality studies have shown the drug works for that and it has significant safety concerns.

The FDA warned doctors late last month against prescribing the drug outside of hospital or research settings, due to risks of sometimes fatal heart side effects. The agency made the announcements after receiving new reports of injury and death with the medication, which is also used to treat lupus and rheumatoid arthritis.

Two small studies published Friday add to concerns about hydroxychloroquine. Critically ill COVID-19 patients given the pill-based drug were prone to heart rhythm problems, and for many risks mounted when it was combined with an antibiotic, the studies found.

O’Day, in a freshly-aired Interview with NBC, said, “Our scientists are hard at work to see now that we know that this medicine has an impact on patients.. if we can bring it earlier into the disease.”

Meanwhile, coronavirus deaths in DC, Virginia and Maryland surpassed 2,000 on Friday as the district recorded its largest number of daily infections.

The three jurisdictions reported 85 new COVID-19 fatalities, bringing the regional total past another grim milestone. A surge in known DC cases announced Friday coincided with the first day the city received more than 1,000 test results in a single day.

The District added seven deaths, bringing its total to 232. The city also added 335 new infections, its largest single-day increase so far.

Virginia reported an additional 26 deaths for a total of 583 fatalities. On Friday, the state posted 94 new COVID-related hospitalizations.

Maryland reported 52 new deaths, 29 of which were not listed with a known locality. It also added 1,730 new infections, the highest number this week

Maryland Gov Larry Hogan (R) has estimated that the first phase of reopening

could happen in early May, saying he is primarily focused on a downward trend in hospitalizations and intensive care unit bed use, neither of which has happened.

When independent experts monitoring the study called with the news that the drug was working, study leader Dr Andre Kalil of the University of Nebraska said he was “almost speechless” with joy.

Here are some questions about the results and next steps.

Question: How much does the drug

help?

Answer: Remdesivir reduced the time patients were in the hospital by 31 percent to 11 days on average versus 15 days for those just given usual care, preliminary results of the study found.

The drug also might be reducing deaths, although that’s not certain from the partial results revealed so far.

About 8 percent of those on the drug died versus 11.6 percent of the comparison group, but the difference is not large enough for scientists to say for sure that the drug was the reason.

Q: What about folks with milder illness? A: Remdesivir so far has only been tested in people with moderate to severe illness who were hospitalized and got it through an IV.

Even among those in the study there was “a very big span of illness,” from people just needing a little extra oxygen to those requiring breathing machines, said Dr Elizabeth Hohmann, who enrolled 49 patients in the study at Massachusetts General Hospital.

“We need more information to see how best to use it going forward” and which types of patients get the most benefit, she said.

Q: When will it be available and for whom?

A: The drug is not yet approved anywhere in the world for any use. The FDA could make it immediately available through an “emergency use authorization,” which speeds experimental drugs, tests and other medical products to patients during public health crises. Under the authorization, the agency can waive the usually rigorous standards necessary for drug approval and instead approve drugs whose potential benefits outweigh their risks.

The FDA has already done that for hydroxychloroquine, a malaria drug President Donald Trump has touted for COVID-19, despite no clear evidence it works.

Fauci said on NBC’s “Today” show Thursday morning that he expects remdesivir to get emergency use approval “really quickly,” and that he spoke with FDA commissioner Stephen Hahn about it Wednesday evening.

Q: How much remdesivir is there and what will it cost?

A: Gilead has or is close to having 140,000 treatment courses now and will donate them, Chairman Daniel O’Day said in a letter to the public Wednesday night. The company aims to have made a total of 500,000 treatment courses by October and more than 1 million by December.

Gilead’s own testing, also revealed on Wednesday, suggests that five days of treatment are as good as 10, so the estimates of how many people can be treated with the available supply likely can be doubled, he added.

Q: How might having a treatment affect the impact of the pandemic?

A: Having to spend less time in the hospital reduces the risk patients will develop complications, such as other infections, or spread the virus to healthcare workers, Kalil said.

Those benefits extend not just to the patients who receive the drug but to others as well, said Dr Aneesh Mehta, who enrolled 103 patients on the study at Emory and other Atlanta hospitals

“We create more availability in our hospitals,” and can take care of more patients with other medical problems, including those who have been forced to delay surgeries for cancer, bad hearts and other maladies, Mehta said.