loader image
Thursday, March 28, 2024
56.3 F
McAllen
We Welcome your Press Release
- Advertisement -

FDA Approves First COVID-19 Treatment for Young Children

Translate to Spanish or other 102 languages!

Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds). Image for illustration purposes
Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds). Image for illustration purposes

Mega Doctor News

- Advertisement -

Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are:

  • Hospitalized, or
  • Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. 

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population. 

Before now, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with COVID-19. 

- Advertisement -

“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”

Veklury is not a substitute for vaccination in individuals for whom COVID-19 vaccination and booster doses are recommended. The FDA has approved two vaccines, and three vaccines are available for emergency use, to prevent COVID-19 and the serious clinical outcomes associated with COVID-19, including hospitalization and death. The FDA urges the public to get vaccinated and receive a booster when eligible. Learn more about FDA-approved and authorized COVID-19 vaccines.

Given the similar course of COVID-19 disease in adults and pediatric patients, today’s approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults. Information on the trials in adults can be found in the FDA-approved drug labeling for Veklury. This approval is also supported by a phase 2/3, single-arm, open-label clinical study of 53 pediatric patients at least 28 days of age and weighing at least 3 kilograms (about 7 pounds) with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19. Patients in this pediatric phase 2/3 trial received Veklury for up to 10 days. The safety and pharmacokinetic results from the phase 2/3 study in pediatric subjects were similar to those in adults.

The only approved dosage form is Veklury for injection.  

- Advertisement -

Possible side effects of using Veklury include increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering.

The FDA granted approval to Gilead Sciences Inc.

- Advertisement -
- Advertisement -

- Advertisement -

More Articles

Dr. Andrew W. Phillips and the Pioneering ECMO Program at DHR Health

In a year marked by significant medical advancements within the Rio Grande Valley, DHR Health's celebration of the first anniversary of its Extracorporeal Membrane Oxygenation (ECMO) program stands out as state-of-the-art innovation and hope.

DHR Health Physicians, First in Texas to Offer Innovative Patient-Centric Treatment for Urge Urinary Incontinence

UUI, also known as urgent bladder leaks, is a common and often embarrassing problem.

Rene Luna, MD, celebrates 1,000th Robotic Surgical Procedure

Dr. Luna is considered one of the most experienced robotic surgery experts in Texas. 

DHR Health Brownsville Hospital, A Pillar of Community Support at the Sombrero Festival

Aida Coronado Garcia, the Chief Operating Officer of DHR Health Brownsville Hospital, was enthusiastic about the hospital's involvement in the event.
- Advertisement -
×