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 todayโs 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.
โAs 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,โ said Patrizia Cavazzoni, M.D., director of the FDAโs Center for Drug Evaluation and Research. โTodayโs approval of the first COVID-19 therapeutic for this population demonstrates the agencyโs commitment to that need.โ
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, todayโs 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.
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.
Additional Resources:
Source: FDA
- Many older adults lack clear eyesight, even with glasses
Vision impairment disproportionately impacts older adults Newswise โ New research shows that 28% of people over the age of 71 have a visual โฆ Many older adults lack clear eyesight, even with glasses TNCRod Washington:ย ย Rod is a blogger, writer, filmmaker, photographer, daydreamer who likes to cook. Rod produces and directs the web series, CUPIC: Diaryโฆ Read more: Many older adults lack clear eyesight, even with glasses - Stork Club Announces the First Gender-Inclusive Reproductive Hormone Therapy Coverage to Address Growing Demand
Leading family-building management solution is the only employer-sponsored program to close gaps in hormone therapy care for all genders: menopause, hormonal health optimization and gender-affirming care - OBSERVING WORLD AIDS DAY
WORLD AIDS DAY Every year, World AIDS Day is held on December 1st to raise awareness of the AIDS pandemic and to mourn those who have died from the disease. According to the most recent statistics, nearly 38 million people around the world are living with HIV. The Human Immunodeficiency Virus is the virus thatโฆ Read more: OBSERVING WORLD AIDS DAY - The undying holiday-suicide myth
Some news media stories still inaccurately link suicide with the holiday season Newswise โ PHILADELPHIA โ The holiday-suicide myth, the false claim that the suicide rate rises during the year-end holiday season, persisted in some news coverage through the 2021-22 holidays, according to U.S. media data collected and analyzed by theย Annenberg Public Policy Centerย (APPC) ofโฆ Read more: The undying holiday-suicide myth - American Indian Teens Who Anticipate Future Affiliation with their Native Culture Experience Fewer Negative Consequences of Drinking
Newswise โ American Indian (AI) adolescents who expect to relate strongly to their racial culture in the future are less likely than their peers to experience negative alcohol outcomes – like fighting with friends, being arrested, and memory gaps – even if they do not relate strongly to their culture now, a new study suggests.โฆ Read more: American Indian Teens Who Anticipate Future Affiliation with their Native Culture Experience Fewer Negative Consequences of Drinking
Rod Washington:ย ย Rod is a blogger, writer, filmmaker, photographer, daydreamer who likes to cook. Rod produces and directs the web series, CUPIC: Diary of an Investigator. He also produces news and documentary video projects. Check out his podcast StoriesThisMoment atย https://m3e.d71.myftpupload.com/stm-tncn-podcasts/
