The Food and Drug Administration announced Thursday that it officially approved remdesivir as the first drug to treat Covid-19. This is a move to show government confidence in safe and effective use for inpatients.
According to the FDA, the drug has been approved for adult and pediatric patients over the age of 12, weighing over 40 kilograms and requiring hospitalization for Covid-19, a disease caused by the coronavirus. is. 220,000 in the United States.
The FDA granted urgent approval for remdesivir in May after a study by the National Institutes of Health found that recovery times for inpatients were reasonably reduced. President Trump received an antiviral drug after he began to show symptoms earlier this month. This drug does not prevent death from Covid-19.
Formal approval by the FDA has shown that the drug has cleared stricter regulatory hurdles, including a more thorough review of clinical data and manufacturing quality, since the urgent approval was given in May.
“The FDA is committed to promoting the development and availability of Covid-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Dr. Stephen M. Hahn. Said in a statement. “Today’s approval is supported by data from multiple clinical trials that have been rigorously evaluated by the authorities and represents an important scientific milestone in the Covid-19 pandemic.”
Originally developed as a treatment for Ebola and hepatitis C, remdesivir blocks the growth of the virus by invading new viral genes. A study of more than 11,000 people in 30 countries sponsored by the World Health Organization found that the drug was unable to prevent the death of Covid-19 patients.
The drug did not go through an external panel of experts called an advisory board before it was approved.
Dr. Peter Lurie, a former deputy member of the FDA and now director of the Center for Public Interest Sciences, said it was not uncommon.
“The FDA tends to choose the drugs that pose the most new and safety issues for the advisory board, and the drugs that are the closest call for efficacy,” Dr. Lurie said. “It’s not a blockbuster drug. It’s not a big step forward. It’s a drug that looks compelling to benefit patients, but it’s not a cure for some kind of miracle.”
Thursday’s approval did not cover the entire population covered under the authorities’ emergency approval in May.
This urgent approval allows physicians to use the drug in inpatients weighing 3.5 to 40 kilograms (not 8 pounds) or inpatients weighing 3.5 kilograms or more and under 12 years of age. According to the FDA, clinical trials are underway to evaluate the safety and efficacy of the drug in this pediatric patient population.
The drug was approved within two weeks of the election day because Mr. Trump had promised a “cure” for Covid-19. Gilead Sciences shares, which make Remdesivir, rose Thursday in news of the FDA’s actions.
“As part of the FDA’s Acceleration of Coronavirus Treatment Program, the FDA will help deliver new medical products to patients as soon as possible while at the same time determining if they are effective and if their benefits outweigh the risks. I will do it, “said Dr. Hahn.
Gina Kolata and Sheila Kaplan contributed to the report.