Her er mer info for den som foretrekker å unngå synsing om hva anerkjennelsen av Remdesivir betyr i praksis:
The drug was approved less than two weeks before Election Day, amid a campaign overshadowed by the pandemic. Mr. Trump, widely criticized over his administration’s handling of the crisis, has repeatedly promised a “cure” as the virus spreads to all corners of the country, and skeptics have expressed concerns about the politicization of health agencies.
Before its approval, remdesivir did not go through an outside panel of experts, called an advisory committee. But Dr. Peter Lurie, a former associate commissioner with the F.D.A. who is now president of the Center for Science in the Public Interest, said that was not unusual.
“The F.D.A. tends to pick for advisory committees those drugs that are most novel and those that present safety issues, and those that are close calls with respect to effectiveness,” Dr. Lurie said. “This is not a blockbuster drug. This is not some massive breakthrough. It’s a drug that appears convincingly to benefit patients, but it’s not some kind of miracle cure.”
A study of more than 11,000 people in 30 countries sponsored by the World Health Organization found that the drug failed to prevent deaths in patients with Covid-19.
Remdesivir, which was originally developed as a treatment for Ebola and hepatitis C, interferes with the reproduction of viruses by jamming itself into new viral genes.
The F.D.A. approval Thursday did not apply to the entire population that was covered under the agency’s emergency authorization in May.
That emergency authorization allows doctors to use the drug on hospitalized pediatric patients weighing between 3.5 kg and 40 kg or hospitalized pediatric patients less than 12 years of age who weigh at least 3.5 kg. Clinical trials assessing the safety and efficacy of the drug in this pediatric patient population are still continuing, the F.D.A. said.
Shares of Gilead Sciences, the company that makes remdesivir, rose on Thursday amid news of the F.D.A. action.
Så det virker som en ganske begrenset pasientgruppe som kan få foreskrevet Remdesivir.