By Cara Murez and Robin Foster HealthDay Reporters
HealthDay Reporter
TUESDAY, April 26, 2022 (HealthDay Information) – The U.S. Meals and Drug Administration on Tuesday accepted the antiviral remdesivir as the primary COVID-19 therapy for younger youngsters.
The drug had to this point solely been accessible to this age group beneath a particular FDA emergency use authorization order.
Now, medical doctors treating children beneath 12 who’re hospitalized or are at residence 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 may cause extreme sickness in youngsters, a few of whom don’t presently have a vaccination choice, there continues to be a necessity for protected and efficient COVID-19 therapy choices for this inhabitants,” Dr. Patrizia Cavazzoni, director of the FDA’s Heart for Drug Analysis and Analysis, stated in an company information launch.
“Right this moment’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 probably present significant medical enchancment, by decreasing illness development and serving to youngsters recuperate from COVID-19 extra rapidly,” stated Dr. Amina Ahmed, from Atrium Well being-Levine Youngsters’s Hospital in Charlotte, N.C. “We want confirmed antiviral therapy 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 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 stated. Folks must also obtain a booster, if eligible, the company added.
The approval was primarily based on outcomes from a part 3 clinical trial for adults, the FDA stated, noting that the course of the illness is comparable in each grownup and pediatric sufferers.
Continued
It is usually supported by a part 2/3 medical research of 53 pediatric sufferers, the FDA stated. Sufferers in that research had a confirmed COVID an infection starting from gentle to extreme and obtained the treatment for 10 days. Outcomes, together with security outcomes, had been much like these already seen in adults, the company stated.
Doable unintended 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 adjustments in blood stress and heart rate, low blood oxygen degree, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating or shivering.
Extra data
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
