By Cara Murez and Robin Foster HealthDay Reporters
TUESDAY, April 26, 2022 (HealthDay Information) – The U.S. Meals and Drug Administration on Tuesday permitted the antiviral remdesivir as the primary COVID-19 remedy for younger youngsters.
The drug had up to now solely been accessible to this age group below a particular FDA emergency use authorization order.
Now, docs treating children below 12 who’re hospitalized or are at house with mild-to-moderate COVID however a excessive threat for extreme COVID can readily prescribe Veklury (remdesivir) to their younger sufferers. Remdesivir had already been totally permitted to deal with individuals 12 and older.
“As COVID-19 may cause extreme sickness in youngsters, a few of whom don’t at the moment have a vaccination possibility, there continues to be a necessity for protected and efficient COVID-19 remedy choices for this inhabitants,” Dr. Patrizia Cavazzoni, director of the FDA’s Middle for Drug Analysis and Analysis, mentioned in an company information launch.
“As we speak’s approval of the primary COVID-19 therapeutic for this inhabitants demonstrates the company’s dedication to that want.”
In a news release from drug maker Gilead Sciences, one pediatric infectious illnesses physician welcomed the information.
“This approval implies that remdesivir can doubtlessly present significant medical enchancment, by lowering illness development and serving to youngsters get well from COVID-19 extra shortly,” mentioned Dr. Amina Ahmed, from Atrium Well being-Levine Youngsters’s Hospital in Charlotte, N.C. “We’d like confirmed antiviral remedy choices, like remdesivir, that may assist deal with a few of the most weak in our society: youngsters.”
The FDA famous that Veklury just isn’t an alternative to getting a vaccination, though there may be not but a vaccine permitted for youngsters aged 4 and youthful. Two COVID vaccines, Pfizer and Moderna, have been totally permitted and three can be found for emergency use, relying on age. The vaccines are supposed to forestall severe medical outcomes, together with hospitalization and dying, the FDA mentioned. Individuals must also obtain a booster, if eligible, the company added.
The approval was primarily based on outcomes from a section 3 medical trial for adults, the FDA mentioned, noting that the course of the illness is comparable in each grownup and pediatric sufferers.
It’s also supported by a section 2/3 medical research of 53 pediatric sufferers, the FDA mentioned. Sufferers in that research had a confirmed COVID an infection starting from gentle to extreme and acquired the treatment for 10 days. Outcomes, together with security outcomes, had been just like these already seen in adults, the company mentioned.
Attainable unwanted effects of the drug, which may solely be delivered by way of injection, embrace increased levels of liver enzymes, which can be an indication of liver damage; and allergic reactions, which can embrace modifications in blood stress and coronary heart charge, low blood oxygen degree, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating or shivering.
The U.S. Facilities for Illness Management and Prevention has extra on COVID-19.
SOURCE: U.S. Meals and Drug Administration, information launch, April 25, 2022