TUESDAY, April 26, 2022 (HealthDay Information) – The U.S. Meals and Drug Administration on Tuesday accepted the antiviral remdesivir as the primary COVID-19 remedy for younger kids.
The drug had thus far solely been obtainable to this age group below a particular FDA emergency use authorization order.
Now, docs treating children below 12 who’re hospitalized or are at dwelling 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 accepted to deal with folks 12 and older.
“As COVID-19 could cause extreme sickness in kids, 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.
“At this time’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 signifies that remdesivir can probably present significant medical enchancment, by lowering illness development and serving to kids get well from COVID-19 extra rapidly,” 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 number of the most susceptible in our society: kids.”
The FDA famous that Veklury isn’t an alternative choice to getting a vaccination, though there may be not but a vaccine accepted for kids aged 4 and youthful. Two COVID vaccines, Pfizer and Moderna, have been totally accepted and three can be found for emergency use, relying on age. The vaccines are supposed to forestall critical medical outcomes, together with hospitalization and demise, 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 clinical 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 examine of 53 pediatric sufferers, the FDA mentioned. Sufferers in that examine had a confirmed COVID an infection starting from delicate to extreme and acquired the medicine for 10 days. Outcomes, together with security outcomes, have been much like these already seen in adults, the company mentioned.
Attainable unwanted side effects of the drug, which may solely be delivered through injection, embody increased levels of liver enzymes, which can be an indication of liver harm; and allergic reactions, which can embody adjustments in blood strain and heart rate, 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