Northwest Arkansas Democrat-Gazette
FDA OKs remdesivir as a covid treatment
U.S. regulators Thursday approved the first drug to treat covid-19 — remdesivir, an antiviral medicine given intravenously to hospitalized patients.
The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the National Institutes of Health.
It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating covid-19. President Donald Trump received it when he was sickened earlier this month.
“We now have enough
Veklury is approved for people at least 12 years old and weighing at least 88 pounds who are hospitalized for a coronavirus infection. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization.
knowledge and a growing set of tools to help fight covid- 19,” Gilead’s chief medical officer, Dr. Merdad Parsey, said in a statement.
The drug is either approved or has temporary authorization in about 50 countries, he noted.
Veklury is approved for people at least 12 years old and weighing at least 88 pounds who are hospitalized for a coronavirus infection. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization.
The drug works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it’s safe for them and to monitor for any possible side effects. And the label warns against using it with the malaria drug hydroxychloroquine because that can curb its effectiveness.
Its price has been controversial, given that no studies have found it improves survival. Last week, a large study led by the World Health Organization found the drug did not help hospitalized covid-19 patients, but that study did not include a placebo group and was less rigorous than previous ones that found a benefit. The FDA’s approval statement noted that, besides the study led by the National Institutes of Health, two others found the drug beneficial.
Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income and other factors.
So far, only steroids such as dexamethasone have been shown to cut the risk of dying of covid-19. The FDA also has given emergency authorization to using the blood of survivors, and two companies are seeking similar authorization for experimental antibody drugs.
VACCINES AWAITED
Separately, vaccines against covid-19 are inching closer, and the FDA may have to decide by year’s end whether to allow use of the first vaccines. On Thursday, a federal advisory committee pulled back the curtain on that decision process in daylong discussions to be sure corners aren’t cut.
The panel, called the Vaccines and Related Biological Products Advisory Committee, is made up mostly of academic experts in infectious diseases, immunology and biostatistics. Some members recused themselves because they work at hospitals where coronavirus vaccine trials are being conducted or are involved in the trials.
They were replaced by temporary members, including Arnold Monto, a University of Michigan epidemiologist who will serve as committee chairman, according to documents on the FDA website.
“Vaccine development can be expedited. However, I want to stress that it cannot — and must not — be rushed,” Dr. Marion Gruber, director of the FDA’s vaccine research office, told the advisers.
Gruber said the public scrutiny “is critical to build trust and confidence” in whichever vaccines emerge.
Exactly how much data the FDA needs to be sure a vaccine is safe and effective is a key question for the advisers,
and one looming as a key vaccine developer, Moderna Inc., announced Thursday the final study of its shot has completed enrollment.
The FDA’s Dr. Doran Fink made clear the agency wants vaccine makers to keep as many volunteers enrolled in their studies for as long as possible to determine longterm vaccine safety and effectiveness.
“Once a decision is made to unblind an ongoing placebo-controlled trial, that decision cannot be walked back and that controlled follow-up is lost forever,” Fink said. But asked how to avoid losing that crucial information, he acknowledged: “I don’t have any specific remedies to offer at this time.”
TRYING TO REASSURE
Thursday ’ s meeting wasn’t to evaluate any particular shots. The FDA has pledged to reconvene its advisers to publicly analyze every vaccine before the agency decides its fate. But it was
an opportunity for the FDA to try and assure the public that science-driven vetting of covid-19 vaccines is happening.
“The visual of scientists sitting around the table carefully discussing what a safe and effective vaccine might look like is an important moment for the FDA,” said Jason Schwartz, assistant professor of health policy and management at the Yale School of Public Health.
“For months, all the FDA could do was offer promises about how science would guide its decisions on the vaccine. This shows how that will happen as data begins to come in.”
The FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from covid-19 — older adults, members of minority groups and anyone with other health problems.
While even a study of 30,000 people cannot spot a side effect that strikes only 1 in 100,000, the government is planning extra scrutiny of every covid-19 vaccine to hit the market.
At first there will be limited doses given to just certain high-risk people — and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.
The FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.
U.S. DEATHS RISING
Meanwhile, covid- 19 deaths are increasing in the U.S. after months of decline, driven by sharp increases in the Midwest and select states in the West.
The seven- day average of newly reported deaths Wednesday hit the highest in a month, according to the
Covid Tracking Project’s most recent data.
The country recorded 994 confirmed and probable deaths, pushing the seven- day average to 757, according to the group. The numbers are about a third of April’s peaks, but appear to be starting a third ascent.
The Dakotas and Montana have turned into the deadliest places per capita, based on the average in the past week, but deaths are also rising in the Northeast, albeit from a low base. The situation is likely to worsen: Cases and hospitalizations have risen more sharply than deaths from recent lows, and the resurgence that started in the Upper Midwest — especially in rural areas — has already gotten much wider.
The South is a major contributor to the national toll, partly because it’s so populous: The region, as defined by the Census Bureau, is roughly equivalent to the Northeast and Midwest combined.
The U. S. added 63,372 cases Wednesday, pushing the seven-day average to the highest since Aug. 3, according to Johns Hopkins University data. There have been more than 220,000 deaths.
According to Covid Tracking Project data, the Midwest surge is continuing, and it’s approaching the high-water mark of the South’s June-July viral wave — about 315 daily cases per million residents. Seven-day average cases in the Northeast reached the highest since May, but it’s still the least-concerning region by cases per capita.
The Northeast is also testing more aggressively than anywhere else. In the past week, it accounted for about 27% of all U. S. tests and around 9% of new positives.
Rhode Island, Ohio and Wyoming all hit single-day record cases Wednesday.